BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3062584 · Received March 18, 2013

    Report

    Report Number
    1218950-2013-00944
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Report Date
    February 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DECLINED PHILIPS EVALUATION/REPAIR. THE HOSPITAL BIOMED EVALUATED THE DEVICE. THE DEVICE PASSED ALL TESTING. THE CUSTOMER STATED THE SYMPTOM MAY HAVE BEEN THE RESULT OF A USE ERROR WHERE THE PADS WERE NOT SECURELY FITTED INTO THE THERAPY CABLE. THE DEVICE PASSED ALL TESTING AND REMAINS IN SERVICE. THE CUSTOMER REPORTED A FAILURE TO DISCHARGE, BUT THE SYMPTOM COULD NOT BE REPRODUCED. WE ARE UNABLE TO DETERMINE THE CAUSE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO DISCHARGE. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111581 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1