BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3230503 · Received July 16, 2013

    Report

    Report Number
    3015876-2013-00628
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND HAS BEEN UNABLE TO DUPLICATE THE REPORTED FAILURE. IT WAS OBSERVED THROUGH AN ELECTRONIC PATIENT RECORD CREATED DURING TESTING, THAT THE DEVICE LOST POWER SEVERAL TIMES. 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

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND HAS BEEN UNABLE TO DUPLICATE THE REPORTED FAILURE. IT WAS HOWEVER OBSERVED THROUGH AN ELECTRONIC PATIENT RECORD CREATED DURING TESTING, THAT THE DEVICE HAD MULTIPLE INDICATIONS OF "POWER OFF" AND "POWER ON". PHYSIO REPLACED THE BATTERY PINS AS A PRECAUTION AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE HAD LOST POWER AND POWERED ITSELF BACK ON. THIS ISSUE COULD PROHIBIT USE OF THE DEVICE ON A PATIENT, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329433 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1