BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2961730 · Received January 14, 2013

    Report

    Report Number
    1218950-2013-00173
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Report Date
    December 18, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    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 DEVICE FAILED TO CHARGE. NO ADVERSE PATIENT IMPACT WAS REPORTED. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. THE SYMPTOM COULD NOT BE DUPLICATED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. WE ARE UNABLE TO DETERMINE THE CAUSE, SINCE THE SYMPTOM WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO CHARGE. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20232 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1