BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2941982 · Received December 22, 2012

    Report

    Report Number
    1218950-2012-04231
    Event Type
    Malfunction
    Date Received
    December 22, 2012
    Report Date
    November 27, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM WAS VERIFIED. THE ISSUE WAS LOCALIZED TO THE PROCESSOR PCA. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND WAS SHIPPED BACK THE CUSTOMER. THIS WAS A MALFUNCTION OF THE PROCESSOR PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE LOCKS UP DURING OPERATIONAL CHECK. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1