URGENT - Medical Device Correction

Transcription

1 Patient Monitoring -1/5- FSN A 09 November 2012 Dear Customer, A problem has been detected with the (PIIC) and Philips IntelliVue Information Center ix (PIIC ix) product that, if it were to occur, could pose a risk for patients. This Field Safety Notice is intended to inform you about: what the problem is and under what circumstances it can occur the actions that should be taken by the customer / user in order to prevent risks for patients or users the actions planned by Philips to correct the problem. This document contains important information for the continued safe and proper use of your equipment Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication. Please retain a copy of this Notice. Philips has identified that an internal audio cable connector may have diminished retention force due to damaged contacts. This diminished retention force could lead to. This issue affects all PIIC and PIIC ix products using Hewlett Packard rp5800 PCs; as noted in the attached affected product list. Philips is conducting this voluntary correction to replace the audio cable on affected devices. Please refer to the following pages, which provide instructions for actions to be taken. Follow the Action to be taken by Customer/User section of the instructions. This issue has been reported to the appropriate regulatory agencies. Ensuring that you have the highest quality medical devices, accessories and supporting documentation is our top priority. Your satisfaction with Philips products is very important to us. Should you have any questions or concerns about this Device Correction, please contact your local Philips representative at : ViCare Medical A/S Att.: Mads-Ole Randskov på tlf eller mor@vicaremedical.dk Sincerely, Tom Fallon Director of Quality & Regulatory Affairs Attachment

2 Patient Monitoring -2/5- FSN A 09 November 2012 AFFECTED PRODUCTS The following PIIC products are affected: PIIC Description Product Number Software Version M M3140 Information Center Low Acuity M3150 Information Center Local DB M3155 Information Center NW DB M3145 Information Center Small NW DB M3151 Information Center Client M3177 Trend Display M3170 Patient Link M3140 Upgrade M3150 Upgrade M3151 Upgrade M3145 Upgrade M3155 Upgrade Software Version N M3151 Information Center Client M3177 Trend Display M3145 Information Center Small NW DB M3155 Information Center NW DB M3170 Patient Link M3140 Upgrade M3150 Upgrade M3151 Upgrade M3145 Upgrade M3155 Upgrade M3140 Information Center Low Acuity M3150 Information Center Local DB The following PIIC ix products are affected: System Serial Number System serial number beginning with 5226 PIIC ix Manufacturing Date Description Product Number Code IntelliVue Info Center ix , , PIIC ix HW Upgrade , PIIC Classic Upgrade and

3 Patient Monitoring -3/5- FSN A 09 November 2012 PROBLEM DESCRIPTION HAZARD INVOLVED An internal audio cable connector may have diminished retention force due to damaged contacts. This diminished retention force may lead to intermittent or loss of audible alarms. Failure to annunciate audio alarms may delay recognition of an alarm condition, if users do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system, e.g., a bedside monitor. This may result in delayed treatment of the patient.

4 Patient Monitoring -4/5- FSN A 09 November 2012 HOW TO IDENTIFY AFFECTED PRODUCTS PIIC The affected product can be identified by the system serial number. The system serial number is included on the device s product label, located on the top of the device: System serial number The affected systems have a system serial number beginning with PIIC ix The affected product can be identified by the manufacturing date code. The manufacturing date code is included on the device s product label, located on the top of the device: Manufacturing date code The affected systems have a manufacturing date code of: , , , and ACTIONS PLANNED BY PHILIPS A representative will contact customers with affected devices to arrange for the replacement of the audio cable on affected units. Philips will replace the audio cable for all affected devices at no charge.

5 Patient Monitoring -5/5- FSN A 09 November 2012 ACTION TO BE TAKEN BY CUSTOMER / USER Observe your system for any of the described symptoms. If you experience intermittent audio or there is no audio from the PIIC / PIIC ix, while it is not connected to another audible alarm annunciation system, do not rely exclusively on the audible alarm system for patient monitoring. As this issue does not affect video functionality, visual alarming remains operational, provide close observation of the PIIC / PIIC ix display. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment. Contact your local Philips representative. FURTHER INFORMATION AND SUPPORT If you need any further information or support concerning this issue, please contact your local Customer Service representative : ViCare Medical A/S Att.: Mads-Ole Randskov på tlf eller mor@vicaremedical.dk