BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 2873901 · Received December 14, 2012

    Report

    Report Number
    3015876-2012-00901
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 20, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED DEVICE FAILURE TO BOOT UP PROPERLY. PHYSIO CONTINUES TO INVESTIGATE THE REPORTED EVENT AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    FURTHER EVALUATION OF THE DEVICE AT PHYSIO-CONTROL'S FAILURE ANALYSIS CENTER DETERMINED THE CAUSE FOR THE MALFUNCTION TO BE FAILURE OF A CRYSTAL OSCILLATOR, DESIGNATOR Y4, ON THE DIGITAL PCB ASSEMBLY.

    Description of Event or Problem · 1

    DURING INSPECTION, THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO BOOT UP PROPERLY. THE DEVICE IMMEDIATELY TURNED ON UPON A BATTERY INSERTION AND THE ON AND SHOCK BUTTONS WERE ILLUMINATED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1