BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 6118026 · Received November 21, 2016

    Report

    Report Number
    3015876-2016-01429
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 21, 2016
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K142430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).  PHYSIO-CONTROL EVALUATED THE CUSTOMER'S DEVICE BUT WAS UNABLE TO DUPLICATE THE REPORTED ISSUE.  AS A PRECAUTION, PHYSIO REPLACED THE POWER PCB ASSEMBLY AND 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

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE POWERED OFF TWICE BY ITSELF WHILE TRYING TO MONITOR A PATIENT WHO WAS EXPERIENCING CHEST PAINS.  A SECOND AMBULANCE (WITH A BACKUP DEVICE) WAS CALLED IN TO TAKE OVER PATIENT CARE.   THE CUSTOMER ADVISED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768274 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR