BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3060709 · Received March 26, 2013

    Report

    Report Number
    1218950-2013-01045
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 4, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE PACER WAS NOT WORKING. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS SENT TO THE PHILIPS BENCH FOR EVAL. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED. THERE WERE ERROR CODES 90007/08 NOTED IN THE LOGS. PER THE DISCRETION OF THE BENCH TECHNICIAN THE POWER PCA WAS REPLACED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER SITE FOR USE. THE REPORTED SYMPTOM COULD NOT BE REPRODUCED AND WE ARE THEREFORE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOMS. THE POWER PCA WAS REPLACED PER THE DISCRETION OF THE REPAIR TECHNICIAN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PACER WAS NOT WORKING. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124625 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1