BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3043375 · Received March 11, 2013

    Report

    Report Number
    1218950-2013-00857
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    February 13, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER EVALUATED THE DEVICE. THE ISSUE WAS ISOLATED TO THE THERAPY PCA. THE THERAPY PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE. A MALFUNCTION OF THE THERAPY PCA CAUSED THE REPORTED SYMPTOM. REPLACEMENT OF THE THERAPY PCA RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE CHARGING CIRCUIT DOES NOT REACH PEAK DURING OP CHECK. THERE WAS NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102695 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1