BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2212830 · Received July 12, 2011

    Report

    Report Number
    1218950-2011-01982
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Report Date
    June 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE BATTERY COMPARTMENT B WAS NOT WORKING. THERE WAS NO REPORT OF PT INVOLVEMENT. THIS REPORTED ISSUE COULD IMPACT THE ABILITY OF THE UNIT TO POWER UP. THE UNIT WAS EVALUATED AT THE PHILIPS. THE REPORTED ISSUE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY COMPARTMENT B WAS NOT WORKING. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE - ANDOVER M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1