BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACKAGE, RED 350P, 1X PAD-PAK-03, GERMAN, 350-STR-ST-10

    MDR report key: 14436996 · Received May 19, 2022

    Report

    Report Number
    3004123209-2022-00075
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    May 3, 2022
    Report Date
    August 16, 2022
    Manufacturer
    HEARTSINE TECHNOLOGIES LTD
    Product Code
    NSA
    PMA / PMN Number
    P160008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HEARTSINE TECHNOLOGIES LTD HAS REQUESTED THE RETURN OF THE DEVICE FROM THE DISTRIBUTOR IN ORDER TO INVESTIGATE THE ALLEGED MALFUNCTION. UPON COMPLETION, THE CONCLUSIONS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    HEARTSINE'S INVESTIGATION OF THE DEVICE CONFIRMED THE REPORTED FAULT AS UPON RETURN THE DEVICE WAS UNABLE TO DELIVER A SHOCK. THE REPORTED FAULT WAS ATTRIBUTED TO A FAILED CAPACITOR, WHICH FORMS PART OF THE SWITCHING CIRCUITRY USED TO DELIVER PHASE ONE OF SHOCK DELIVERY.THE DEVICE WAS SCRAPPED BY HEARTSINE AND THE CUSTOMER WAS PROVIDED WITH A REPLACEMENT DEVICE. D2 UPDATE: DUE TO NEW FDA APPROVAL FOR THIS MODEL, THE PRODUCT CODE HAS BEEN UPDATED FROM MKJ TO NSA.

    Description of Event or Problem · 0

    THE DISTRIBUTOR CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DOES NOT GIVE A SHOCK DURING TESTING. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THE DISTRIBUTOR CONTACTED HEARTSINE TO REPORT THAT THEIR DEVICE DOES NOT GIVE A SHOCK DURING TESTING. IN THIS STATE THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848279 PACKAGE, RED 350P, 1X PAD-PAK-03, GERMAN, 350-STR-ST-10 AUTOMATED EXTERNAL DEFIBRILLATOR NSA HEARTSINE TECHNOLOGIES LTD 350P
    392393 PACKAGE, RED 350P, 1X PAD-PAK-03, GERMAN, 350-STR-ST-10 AUTOMATED EXTERNAL DEFIBRILLATOR NSA HEARTSINE TECHNOLOGIES LTD 350P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown