BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY/CPR CABLE

    MDR report key: 4080823 · Received August 25, 2014

    Report

    Report Number
    1218950-2014-05088
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Report Date
    July 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K051134
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE DEVICE DOES NOT RECOGNIZE PADS. THERE IS NO REPORTED PATIENT INVOLVEMENT OR NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510683 THERAPY/CPR CABLE MKJ PHILIPS MEDICAL SYSTEMS M4763A

    Patients

    Seq Age Sex Outcome Treatment
    1