BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 2781558 · Received October 10, 2012

    Report

    Report Number
    3015876-2012-00754
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    July 18, 2012
    Report Date
    July 25, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTION INFORMATION: THE INITIAL MEDWATCH REPORT INDICATES "YES" AND "RETURNED TO MANUFACTURER ON (B)(4) 2012" THE INITIAL MEDWATCH REPORT SHOULD INDICATE "NOT RETURNED TO MANUFACTURER" (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED AN INTERMITTENT FAILURE TO POWER ON. PHYSIO CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: THE THIRD PARTY SERVICE REPRESENTATIVE EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56. FOLLOW UP INFORMATION: THE THIRD PARTY SERVICE REPRESENTATIVE ADVISED PHYSIO-CONTROL THAT THE MAIN PCB ASSEMBLY WAS REPLACED AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE POWER BUTTON WAS INOPERABLE. THE DEVICE COULD NOT BE USED TO PROVIDE DEFIBRILLATION THERAPY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1