BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3840444 · Received May 30, 2014

    Report

    Report Number
    3015876-2014-00599
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EXAMINED THE CUSTOMER'S DEVICE AND VERIFIED THE INTERMITTENT ISSUE. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS THE QUIK-COMBO (QC) THERAPY CABLE. THE CUSTOMER PROVIDED PHYSIO WITH A SPARE QC THERAPY CABLE AND AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE. THE QC THERAPY CABLE WAS DISPOSED OF LOCALLY AND NOT RETURNED TO PHYSIO-CONTROL FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT WHILE TESTING THEIR DEVICE IT WOULD INTERMITTENTLY NOT RECOGNIZE PADDLES LEAD ECG WHEN USED IN CONJUNCTION WITH THEIR QUIK-COMBO THERAPY CABLE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318059 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1