BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1811094 · Received August 12, 2010

    Report

    Report Number
    1218950-2010-01308
    Event Type
    Malfunction
    Date Received
    August 12, 2010
    Report Date
    July 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE FAILS THE DEFIB OPCHECK TEST. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE CUSTOMER STATED THAT THEY CONFIRMED THE FAILURE WITH MULTIPLE KNOWN GOOD ACCESSORIES. THE CUSTOMER ORDERED A REPLACEMENT THERAPY PCA AND THERAPY PORT, AND WILL REPAIR THE DEVICE. PHILIPS DID NOT EVALUATE THE DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILS THE DEFIB OPCHECK TEST. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1