BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3090196 · Received April 19, 2013

    Report

    Report Number
    1218950-2013-01431
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 27, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A FAILURE TO DISCHARGE AND SHOCK BUTTON FAILURE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS SENT TO THE PHILIPS BENCH FOR EVALUATION. THE REPORTED SYMPTOM COULD NOT BE DUPLICATED. HOWEVER, ERRORS IN THE DEVICE LOG VERIFIED THE ISSUE. THE ISSUE WAS LOCALIZED TO THE THERAPY PCA. THE THERAPY PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE THEN PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER SITE FOR USE. WE ARE CONSIDERING THIS A MALFUNCTION OF THE THERAPY PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO DISCHARGE AND SHOCK BUTTON FAILURE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169513 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1