BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3060707 · Received March 26, 2013

    Report

    Report Number
    1218950-2013-01050
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WOULD NOT SYNC CARDIOVERT DURING A PT EVENT. THERE WAS NO NEGATIVE PT IMPACT AS ANOTHER DEFIBRILLATOR WAS AVAILABLE FOR USE. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE SYMPTOM WAS NOT DUPLICATED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO SERVICE. THERE IS NO REQUEST FOR A RESPONSE BY THE CUSTOMER. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED MALFUNCTION. BECAUSE THE PROBLEM COULD NOT BE RECREATED THE CAUSE CANNOT BE DETERMINED. NO FORMAL RESPONSE WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WOULD NOT SYNC CARDIOVERT DURING A PT EVENT. THERE WAS NO NEGATIVE PT IMPACT AS ANOTHER DEFIBRILLATOR WAS AVAILABLE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123048 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1