Do not operate the device in skin temperature mode with temperature sensor without patient contactl

Transcription

1 Dräaer To all operators and users of Babytherm 8004/8010 open care units for premature and newborn patients lmportant safety notice!l! Babytherm 8004/8010 open care units for premature and newborn patients June 2016 Dear Madam/Sir, As part of our market and product monitaring we have become aware of a case in which a Babytherm 8004 without patient was operated in skin temperature mode with skin temperature sensor to prepare it for use. ln skin temperature mode, the radiant warmer output is controlled automatically until the set skin temperature is reached. As a result of operating the temperature sensor without patient contact, the radiant warmer was operated continuously at a high output Ievel. During this forced continuous operation under high thermal Ioad, the heating element aged faster. Apart became detached from the heating element and fell onto the mattress tray \1\fhere a towel caught fire. Do not operate the device in skin temperature mode with temperature sensor without patient contactl To preheat the device, you can use the manual mode up to Ievel 3 as there is no active time Iimit. At Ievel 4 or above, there will be regular alarms. lf the alarm is not acknowledged, the radiantwarmer will be automatically switched off. For further details, please refer to the Babytherm 8004/8010 instructions for use. Additionally, our analyses have shown that the heating elements are not replaced at regular intervals as recommended in the Babytherm instructions for use. We attribute this to the fact that it might not be practicable to replace the heating element after 10,000 operating hours. We have therefore converted this value into a period of 2 years, which can be measured more easily. lf your heating elements have been in operation for more than 2 years, please replace them. Drägerwerk AG & Co. KGaA Moislinger Allee Lübeck, Germany Postal address: Lübeck, Germany TeL {) Fax info@draeger.com VAT ID DE Bank information: Commerzbank AG, Lübeck IBAN: DE Swift Code: COBA OE FF 230 Sparkasse zu Lübeck IBAN: DE Swift code : NOLADE21SPL Company headquarters: Lübeck Commercial register: Municipal Court lübeck HRB 7903 HL General partner: Drägerwerk Verwaltungs AG Company headquarters: Lübeck Commercial register: Municipal Court Lübeck HRB 7395 HL Chairman of the Executive Board for Drägerwerk AG & Co. KGaA and Drägerwerk Verwaltungs AG: Prof. Dr. Nikolaus Schweickart Executive Board: Siefan Dräger (Chairman) Rainer Klug Gert-Hartwig Lescow Dr. Reiner Piske Anton Schrofner

2 ilräger Page 2/2 lf you have any questions regarding orders, please contact your local Dräger representative. lf you have concluded a service contract with us, your responsible Dräger service technician will check the age of your heating elements at the next opportunity and replace them if necessary. We amended our instructions for use by the attached supplement, which contains corresponding notes and warnings. Piease add the supplement to all instructions for use of the Babytherm 8004/8010 and inform any possible users in your facility about it. We regret any inconvenience this information may cause but consider it necessary as a preventive measure to increase patient and user safety. Piease feel free to contact your local Dräger representative if you have any questions. Yours faithfully, Ci~el~ Oliver Möller Post Market Surveillance Quality and Regulatory Affairs lnken Schroeter Product Management Life Support Systems Thermoregulation Attachment: Supplement to the instructions for use of your Babytherm 8004/8010

3 To enable us to monitor the effectiveness of this communication, we request that you sign and return ( or post) the 'Confirmation of Receipt' as below. Important Safety Notice Failure of radiant heaters due to overload and ageing Please list affected devices below:- Part Number Device Machine ID Serial Number Hospital Name: Contact Name: Signature: Date: Should you have any questions, please contact:- Quality Department Draeger Medical UK Limited The Willows, Mark Road Hemel Hempstead Hertfordshire HP2 7BW Tel.: Fax:

4 Babytherm 8004/8010 de Ergänzung, Seite 2 en Supplement, page 4 fr Supplément, page 6 es Suplemento, página 8 it Foglio informativo, pagina 10 pt_ib Documento suplementar, página 12 nl Aanvullingsdocument, pagina 14 da Supplement, side 16 no Vedlegg, side 18 sv Tilläggsinformation, sida 20 fi Lisälehti, sivu 22 pl Suplement, strona 26 cs Dodatek, strana 28 sk Dodatok, strana 30 hu Kiegészítő dokumentum, 32. oldal ro Supliment, pagina 34 sr Dodatak, stranica 36 bg Допълнение, стр. 38 tr Ek, Sayfa 40 zh 增补, 第 42 页 ko 부록, 44 참조 ja 補足文書, 46 ページ WARNING To properly use this medical device, read and comply with these Instructions for Use.

5 English Supplement Babytherm 8004/8010 en English Supplement to the instructions for use Babytherm 8004/8010 with part number: , edition: and earlier Babytherm 8004/8010 (NAWI scale option) with part number: , edition: and earlier Keep this supplement with the instructions for use of the medical device. This supplement updates the information of the instructions for use in the following chapters: For your safety and that of your patients WARNING Risk of overheating of the radiant warmer If the radiant warmer is operated continuously at high output, for example, in skin temperature mode with a temperature sensor and without a patient, the life span of the infrared radiator may be shortened. Do not operate the device in skin temperature mode with a temperature sensor connected and without a patient. Maintenance intervals (in Supplement named Maintenance) Safety checks Safety checks are not a substitute for maintenance, which includes the preventive replacement of wearing parts, as specified by the manufacturer. 1 Check the accompanying documents: The latest version of the instructions for use is available 2 Perform a functional test of the following features according to the instructions for use: Height adjustment The flaps close securely 3 Check that the device combination is in perfect condition: All labels are complete and legible There is no visible damage Fuses which are accessible from the outside are in compliance with the specified values Check the condition of the two heater elements, paying particular attention to signs of thermal overload. 4 Check if the medical device is completely equipped as described in the instructions for use. 4 Supplement Babytherm 8004/8010

6 English 5 Check the electrical safety according to IEC Check the safety features: Mains power supply failure alarm LEDs, display, alarm tone Table of maintenance intervals WARNING Risk due to faulty infrared radiators The heater elements are designed for safe operation within the specified maintenance intervals. Failure to observe the specified maintenance intervals or using the device contrary to its intended use poses a risk to patient safety. Observe the specified maintenance intervals. Component Interval Task Personnel responsible Heating element/infrared radiator After 2 years or 5000 operating hours Exchange in pairs Experts Technical data Radiant warmer Radiant power between the bed and the radiant warmer 1) Heater level 3 max. 10 mw/cm 2 Heater level 10 max. 30 mw/cm 2 1) measured according to IEC Supplement Babytherm 8004/8010 5