BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2882496 · Received December 20, 2012

    Report

    Report Number
    3015876-2012-00928
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE THERAPY PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO FURTHER EVALUATED THE REMOVED THERAPY PCB ASSEMBLY AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO AN ELECTRICALLY LEAKY CAPACITOR, DESIGNATOR C160.

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORT INDICATES: THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT. AFTER AN EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE WOULD NO LONGER DETECT THE THERAPY CABLE ASSEMBLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT. AFTER AN INITIAL EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT MONITOR ECG THROUGH THE THERAPY CABLE AND HARD PADDLES ASSEMBLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT. AFTER AN EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE WOULD NO LONGER DETECT THE THERAPY CABLE ASSEMBLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED THAT THEIR DEVICE HAD A SERVICE INDICATOR PRESENT. AFTER AN INITIAL EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE WOULD NOT MONITOR ECG THROUGH THE THERAPY CABLE AND HARD PADDLES ASSEMBLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1