BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1833969 · Received August 31, 2010

    Report

    Report Number
    1218950-2010-01447
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Report Date
    August 3, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A THERAPY CABLE FAILURE IN TESTING. THERE WAS NO REPORT OF PT INVOLVEMENT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AT THE CUSTOMER SITE, BUT COULD NOT REPRODUCE THE REPORTED SYMPTOM. THE DEVICE PASSED ALL TESTING. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE, SINCE THE SYMPTOM WAS NOT DUPLICATED. AS OF 8/22/10, THERE HAVE BEEN NO FURTHER REPORTS OF THIS SYMPTOM AND THIS DEVICE FROM THIS CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A THERAPY CABLE FAILURE IN TESTING. THERE WAS NO REPORT OF PT 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