BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 2945907 · Received January 7, 2013

    Report

    Report Number
    1218950-2013-00064
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Report Date
    December 11, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE DURING USE. THERE WAS NO NEGATIVE PT IMPACT. THE DEVICE WAS EVALUATED BY A PHILIPS FSE. THE REPORTED SYMPTOM COULD NOT BE DUPLICATED. THERE WERE NO ECG STRIPS OR EVENT SUMMARY AVAILABLE FOR REVIEW. AFTER PASSING ALL PERFORMANCE VERIFICATION TESTING THE DEVICE WAS RETURNED TO USE. THERE IS NO INFO THAT SUPPORTS THAT THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS DURING THIS EVENT. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM AS IT COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE DURING USE. THERE WAS NO NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8539 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1