BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP2

    MDR report key: 1961484 · Received January 10, 2011

    Report

    Report Number
    9610816-2011-00011
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Report Date
    December 20, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K040357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE CUSTOMER HAS APPARENTLY RECOGNIZED THE SPEAKER FAILURE, AND AS NO PT ADVERSE EVENT/ADVERSE PT IMPACT WAS REPORTED TO HAVE RESULTED FROM THIS ISSUE, IT IS CONSIDERED THAT THE ISSUE WAS IMMEDIATELY OBVIOUS TO THE USER. GENERALLY, PT ALARMS & TECHNICAL INOPS WILL CONTINUE TO BE ANNUNCIATED AT THE CENTRAL STATION (IF NETWORKED). THE X2 DISPLAYED "SPEAKER MALF." INOP. IT REMAINS UNCLEAR IF INOP WAS STILL ACCOMPANIED BY SOUNDS FROM THE X2 SPEAKER, OR IF SPEAKER/SOUND FAILED ENTIRELY. IN AN ABUNDANCE OF CAUTION, WE WILL REPORT LOSS OF AUDIO EVEN THOUGH A VISUAL WARNING IS PROVIDED AND PRODUCT LABELING DESCRIBES PERSONAL SURVEILLANCE AND TO NOT RELY EXCLUSIVELY ON THE AUDIBLE ALARM SYSTEM FOR PT MONITORING. ADJUSTMENT OF ALARM VOLUME TO A LOW LEVEL OR OFF DURING PT MONITORING MAY RESULT IN PT DANGER. REMEMBER THAT THE MOST RELIABLE METHOD OF PT MONITORING COMBINES CLOSE PERSONAL SURVEILLANCE WITH CORRECT OPERATION OF MONITORING EQUIPMENT. THE INFECTION ON MONITORING WOULD BE IN CLOSE PERSONAL OBSERVATION AS SPECIFIED IN THE PRODUCT LABELING. THIS WOULD ALERT THE USER TO POSSIBLE DEVICE ISSUE TO TROUBLESHOOT THE DEVICE OR IMPLEMENT ALTERNATIVE MONITORING. THIS WOULD ALLOW THE USER TO IMPLEMENT ALTERNATIVE METHODS OF MONITORING PER HOSPITAL PROTOCOL, AND/OR TO TROUBLESHOOT THE MONITOR. DUE TO AN INCREASED NUMBER OF COMPLAINTS WHERE THE X2/MP2 GENERATED A "SPEAKER MALF." INOP, PHILIPS RECOGNIZED THAT THE FAILURE MODE REQUIRES A DEEPER ANALYSIS. THUS, A SERVICE BULLETIN (SB) SB86201126A HAS BEEN ISSUED TO INFORM A FIELD AUDIENCE ABOUT THE NATURE OF FAILURE MODE (MECHANICAL DEFECT) AND THE ISSUE BEING UNDER INVESTIGATION. THIS SB WAS CONSIDERED A STATUS UPDATE TO THE FIELD UNTIL A LONG TERM SOLUTION IS AVAILABLE. AS OF (B)(4) 2010, THE FDA HAS BEEN NOTIFIED ABOUT MANDATORY FIELD ACTION FCO86201157, WHICH RECALLS ALL X2/MP2 IN A SPECIFIED DEVICE SN RANGE, AS WELL AS EXCHANGE SPEAKER ASSEMBLIES SHIPPED WITHIN SPECIFIED TIME FRAME. ALL SPEAKERS AFFECTED BY THE PROVISIONS OF FCO86201157 WILL BE REPLACED WITH A REVISED DESIGN SPEAKER ASSEMBLY, INCLUDING THE ONE REPORTED IN THIS CASE. PHILIPS WILL INFORM CUSTOMERS ABOUT THIS RECALL VIA FCO86201157 AND WILL BE SENDING EACH AFFECTED CUSTOMER AN URGENT MEDICAL DEVICE CORRECTION NOTIFICATION/FIELD SAFETY NOTICE (FSN86201157). THIS NOTIFICATION EXPLAINS THE ISSUE AND GIVES CUSTOMERS INSTRUCTIONS ON ACTIONS TO TAKE WHILE THEY AWAIT THE CORRECTION, WHICH WILL COME IN THE FORM OF REPLACEMENT SPEAKER ASSEMBLIES. SB86201176A HAS BEEN ISSUED TO INFORM THE PHILIPS FIELD SERVICE ORGANIZATION ABOUT THE FIELD SAFETY NOTIFICATION (SB86201176A). NO FURTHER INVESTIGATION OR ACTION IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED A VISIBLE "SPEAKER MALFUNCTION" INOP. NO PT WAS HARMED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MP2 MHX PHILIPS MEDICAL SYSTEMS M8102A

    Patients

    Seq Age Sex Outcome Treatment
    1