BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 1934127 · Received December 3, 2010

    Report

    Report Number
    3015876-2010-01326
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Report Date
    November 4, 2010
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE BANANA PIN CONNECTOR WAS REPLACED AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FURTHER EVALUATED THE REMOVED CONNECTOR AND OBSERVED THAT THE PINS WERE A SLIGHTLY FLAT AND BLACKENED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THE DEVICE HAD NOISY ECG IN ALL 12 LEADS. THE PT'S OUTCOME, AS WELL AS ANY OTHER PT INFO REGARDING THE EVENT WAS NOT REPORTED. UPON EVALUATION BY PHYSIO-CONTROL, IT WAS OBSERVED THAT THE DEVICE WOULD POWER ITSELF DOWN DURING THE PERFORMANCE INSPECTION PROCEDURE (PIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 15 MONITOR/DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC 15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK