BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_MEDICAL - BELFAST_PRODUCT

    MDR report key: 11628480 · Received April 7, 2021

    Report

    Report Number
    3004123209-2021-00120
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    November 30, 2020
    Report Date
    April 21, 2021
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    MKJ
    PMA / PMN Number
    K014067
    Removal / Correction Number
    Z-0124-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SERIAL NUMBER WAS NOT KNOWN AT THE TIME OF THE INITIAL. THE SERIAL NUMBER HAS SINCE BEEN CONFIRMED AS (B)(6).

    Description of Event or Problem · 0

    DEVICE PLAYED ERROR MESSAGE DURING SCA RESCUE. PATIENT INVOLVEMENT, PATIENT SURVIVED TO HOSPITAL DISCHARGE. DELAY IN SHOCK REPORTED, NO ADVERSE CONSEQUENCES TO PATIENT.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER FOR THE DEVICE HAS BEEN PROVIDED AS (B)(4).

    Description of Event or Problem · 1

    DEVICE PLAYED ERROR MESSAGE DURING SCA RESCUE. PATIENT INVOLVEMENT, PATIENT SURVIVED TO HOSPITAL DISCHARGE. DELAY IN SHOCK REPORTED, NO ADVERSE CONSEQUENCES TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529361 UNKNOWN_MEDICAL - BELFAST_PRODUCT AUTOMATED EXTERNAL DEFIBRILLATOR MKJ HEARTSINE TECHNOLOGIES LTD

    Patients

    Seq Age Sex Outcome Treatment
    1