BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 3003566 · Received February 11, 2013

    Report

    Report Number
    1218950-2013-00494
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 28, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED INTERMITTENT ETCO2 READINGS DURING A PATIENT EVENT. THERE WAS NO NEGATIVE PATIENT IMPACT. THE DEVICE WAS EVALUATED AT PHILIPS, BUT THE SYMPTOM WAS NOT DUPLICATED. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. WE CANNOT DETERMINE THE CAUSE OF THE REPORTED ISSUE, AS THE SYMPTOM WAS NOT DUPLICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT ETCO2 READINGS DURING A PATIENT EVENT. THERE WAS NO NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59238 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1