BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 3043152 · Received March 13, 2013

    Report

    Report Number
    1218950-2013-00892
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 15, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE DEVICE LOCKED UP DURING OP CHECK. THERE WAS NO REPORTED PT INVOLVEMENT. A PHILIPS REPAIR TECHNICIAN EVALUATED THE DEVICE AND DID NOT CONFIRM THE FAILURE. THE PROCESSOR PCA WAS REPLACED FOR PREVENTATIVE MAINTENANCE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO THE CUSTOMER. BASED ON THE CUSTOMER'S REPORT, WE WILL CONSIDER THIS TO BE A MALFUNCTION OF THE DEVICE. WE CANNOT DETERMINE THE CAUSE, SINCE THE SYMPTOM WAS NOT DUPLICATED. AS OF 03/11/2013, THERE HAVE BEEN NO FURTHER CALLS FOR THIS UNIT RELATED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE LOCKED UP DURING OP CHECK. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106259 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1