BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 2883581 · Received December 21, 2012

    Report

    Report Number
    3015876-2012-00937
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 4, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 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 FURTHER EVALUATED THE DEVICE AND DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A CRYSTAL, DESIGNATOR Y4, ON THE DIGITAL PCB ASSEMBLY THAT HAD BECOME THERMALLY REACTIVE. THE CRYSTAL WOULD NOT OSCILLATE UNLESS HEAT WAS APPLIED TO THE PART. THE DEVICE WOULD NOT COMPLETE A BOOT CYCLE IF THE CRYSTAL DID NOT FUNCTION. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER UNDER WARRANTY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL CUSTOMER SERVICE REPRESENTATIVE THAT THE CUSTOMER'S DEVICE DID NOT TURN ON DURING A TRAINING SESSION. LATER ON THE CUSTOMER TRIED TO TURN ON THE DEVICE SEVERAL TIMES, EACH TIME WITH DIFFERENT RESULT. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS 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