BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR

    MDR report key: 2941747 · Received December 21, 2012

    Report

    Report Number
    1218950-2012-04131
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    January 12, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    PMA / PMN Number
    K844740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYMPTOM WAS CLARIFIED AS THE DEVICE FAILED TO POWER UP. THE CUSTOMER LOCALIZED THE ISSUE TO THE BATTERY. THE CUSTOMER WAS GIVEN A QUOTATION FOR REPLACING THE BATTERY. NO FURTHER COMMUNICATION WAS REQUESTED AND NONE IS WARRANTED. THIS WAS MALFUNCTION OF THE BATTERY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE WANTED TO BUY A BATTERY/ BAD BATTERY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEFIBRILLATOR LDD PHILIPS MEDICAL SYSTEMS 43120A

    Patients

    Seq Age Sex Outcome Treatment
    1