BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1646829 · Received March 26, 2010

    Report

    Report Number
    3015876-2010-00397
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    February 25, 2010
    Report Date
    February 25, 2010
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO DETERMINED THE CAUSE OF FAILURE TO BE A LOST CONNECTION BETWEEN THE THERAPY CONNECTOR AND THERAPY PCB; THE LOW VOLTAGE WIRES HAD COME OUT OF THE WIRE HARNESS ON THE THERAPY BOARD. PHYSIO RESEATED THE THERAPY CONNECTOR TO THE THERAPY PCB CONNECTION AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FAILED TO RECOGNIZE THE THERAPY CABLE CONNECTION. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA