BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEFIBRILLATOR

    MDR report key: 2043219 · Received March 15, 2011

    Report

    Report Number
    1218950-2011-00697
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 13, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    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 CUSTOMER REPORTED THAT THE ELECTRIC DRIVE BELT DEFIBRILLATION CAPACITY IS OVER THE LIMIT. THE CUSTOMER WAS INFORMED THAT THIS DEVICE HAS BEEN OUT OF SUPPORT SINCE (B)(4) 1999 AND PARTS ARE NO LONGER AVAILABLE. BASED ON THE CUSTOMER'S REPORT, WE WILL CONSIDER THIS A REPORTABLE MALFUNCTION OF THE UNIT. WE CANNOT DETERMINE THE CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ELECTRIC DRIVE BELT DEFIBRILLATION CAPACITY IS OVER THE LIMIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1