BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 3122991 · Received May 21, 2013

    Report

    Report Number
    3015876-2013-00416
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL PROVIDED THE CUSTOMER TECHNICAL ASSISTANCE AND RECOMMENDED REPLACING THE BATTERY. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION. SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER FOR FURTHER INFORMATION AND/OR DEVICE STATUS HAS BEEN UNSUCCESSFUL.

    Additional Manufacturer Narrative · 1

    (B)(6). SUPPLEMENTAL INFORMATION: PHYSIO-CONTROL'S FOLLOW UP WITH THE CUSTOMER CONFIRMED THAT INSTALLMENT OF A NEW BATTERY RESOLVED THE REPORTED PROBLEM. THE DEVICE POWERED ON WITHOUT ANY ISSUES. THE CAUSE FOR THE REPORTED PROBLEM WAS DUE TO A DEPLETED BATTERY.

    Description of Event or Problem · 1

    DURING AN INSPECTION, THE CUSTOMER FOUND THAT THE DEVICE ILLUMINATED THE SERVICE WRENCH AND BATTERY INDICATORS ON THE READINESS DISPLAY AND IT FAILS TO POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224555 BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1