BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3022781 · Received March 27, 2013

    Report

    Report Number
    3015876-2013-00237
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE DIGITAL PCB ASSEMBLY CAUSED THE DEVICE TO LOCK-UP WITH AN ALERT TONE SOUNDING. IN THE LOCKED-UP STATE, THE DEVICE COULD NOT CHARGE AND SHOCK ENERGY. UPON FURTHER EVALUATION OF THE DIGITAL PCB ASSEMBLY, THE DIGITAL PCB ASSEMBLY STARTED TO OPERATE PROPERLY AND WOULD NO LONGER FAIL. A FURTHER COMPONENT CAUSE COULD NOT BE DETERMINED. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER UNDER WARRANTY.

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL SERVICE REPRESENTATIVE THAT WHEN THE CUSTOMER RECEIVED THEIR NEW DEVICE, THE DEVICE WOULD NOT POWER ON. THE DEVICE ONLY GAVE A HIGH TONE FROM THE SPEAKER AND COULD NOT BE TURNED ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126656 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1