BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2941772 · Received December 21, 2012

    Report

    Report Number
    1218950-2012-04139
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Report Date
    October 21, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE TEST FAILURES. MULTIPLE PARTS WERE REPLACED TO RESOLVE THE ISSUE. AFTER PASSING ALL PERFORMANCE ASSURANCE TESTS THE DEVICE WAS RETURNED TO THE CUSTOMER. NO FURTHER COMMUNICATION WAS REQUESTED AND NONE IS WARRANTED. WE ARE CONSIDERING THIS A MALFUNCTION BUT WE CANNOT DETERMINE THE CAUSE BECAUSE MULTIPLE PARTS WERE REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE SYMPTOMS RELATED TO ECG TEST FAILURES. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1