BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 9267047 · Received November 1, 2019

    Report

    Report Number
    1218950-2019-08336
    Event Type
    Malfunction
    Date Received
    November 1, 2019
    Report Date
    October 23, 2019
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD BENT BATTERY PCA PINS. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD BENT BATTERY PCA PINS. THERE WAS REPORTEDLY NO PATIENT INVOLVEMENT. ONE BATTERY PCA WAS RETURNED FOR EVALUATION. J7 PIN WAS FOUND TO BE BENT / DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059325 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1