BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 3063446 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01144
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    October 8, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER INITIALLY REPORTED: "CAN'T BE DONE CONTINUOUSLY". THE SYMPTOM WAS CLARIFIED TO BE A FAILURE TO POWER UP. NO SERIAL NUMBER WAS PROVIDED. THE CUSTOMER DID THE EVAL OF THE DEVICE. PHILIP PROVIDED THE CUSTOMER WITH AN EVAL/REPAIR QUOTE. THE CUSTOMER DECLINED REPAIR DUE TO THE COST OF THE QUOTE. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED SYMPTOM AS THE CUSTOMER DECLINED TO REPAIR.

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTED: "CAN'T BE DONE CONTINUOUSLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127271 HEARTSTART XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1