BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 5994339 · Received October 3, 2016

    Report

    Report Number
    3015876-2016-01162
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 7, 2016
    Report Date
    October 3, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).  PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE AND VERIFIED THE REPORTED ISSUE.  PHYSIO THEN REPLACED THE POWER PCB ASSEMBLY AND COMPLETED OTHER, UNRELATED, REPAIRS.  AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING THE UNIT WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    DURING THE ANNUAL PREVENTATIVE MAINTENANCE (PM) INSPECTION ON A CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT IT WOULD POWER OFF AND ON BY ITSELF. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646622 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1