BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 7209249 · Received January 22, 2018

    Report

    Report Number
    1218950-2018-00695
    Event Type
    Malfunction
    Date Received
    January 22, 2018
    Report Date
    December 29, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BATTERY PCA WAS RETURNED FOR FAILURE ANALYSIS. THE BATTERY PCA WAS RECEIVED BY THE PHILIPS FA LAB ON (B)(6)2018. THE BATTERY PCA WAS VISUALLY INSPECTED FOR ANY MECHANICAL DAMAGE AND/OR CONTAMINATION AND WAS NONE OBSERVED. THE REPORTED PROBLEM WAS NOT VERIFIED DURING VISUAL INSPECTION. NO FAULT FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICES' BATTERY PCA HAD BENT PINS. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52757 HEARTSTART MRX -EMS DEFIBRILLATOR DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1