BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3062583 · Received March 18, 2013

    Report

    Report Number
    1218950-2013-00941
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Report Date
    February 21, 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 RESPONSE CENTER PROVIDED THE CUSTOMER WITH TROUBLESHOOTING INFORMATION. THE CUSTOMER SUBSEQUENTLY REPORTED THAT REPLACING THE THERAPY PCA RESOLVED THE ISSUE. THIS WAS A MALFUNCTION OF THE THERAPY PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FREEZES DURING OPERATIONAL CHECK. THEY ALSO NOTED ERROR MESSAGES/STATUS LOG ENTRIES RELATED TO THE THERAPY PCA. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111627 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1