BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 1000 DEFIBRILLATOR

    MDR report key: 1964219 · Received December 22, 2010

    Report

    Report Number
    3015876-2010-01409
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S DEVICE WOULD NOT POWER ON. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 1000 DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC. 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA