BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3062585 · Received March 18, 2013

    Report

    Report Number
    1218950-2013-00946
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Report Date
    February 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE MACHINE IS NOT GETTING CHARGED. THIS REPORT WAS LATER CLARIFIED BY THE CUSTOMER THAT THE BATTERY WAS NOT GETTING CHARGED WHILE CONNECTED WITH AC MAINS POWER. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FSE AND THE SYMPTOM WAS NOT DUPLICATED. THE PROBLEM FOUND WITH AC MAINS POWER OUTLET WHERE THE DEVICE WAS CONNECTED TO. THE DEVICE WAS CONNECTED WITH DIFFERENT AC POWER OUTLET AND THE PROBLEM WAS RESOLVED. THE DEVICE WAS RETURNED FOR USE, IT REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MACHINE IS NOT GETTING CHARGED. THIS WAS CLARIFIED BY THE CUSTOMER: CUSTOMER WANTED TO CONVEY, BATTERY NOT GETTING CHARGED WHILE CONNECTED WITH AC MAINS POWER. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112642 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1