BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK

    MDR report key: 7374936 · Received March 27, 2018

    Report

    Report Number
    3007042319-2018-01222
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    August 16, 2017
    Report Date
    May 1, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE REPORTED EVENT, OF CRACKED DISPLAY WINDOW AND TORN SHOULDER PACK, COULD NOT CONFIRMED. THE SHOULDER PACK, LOT # 896450 WAS VISUALLY INSPECTED FOR ANY ANOMALIES AND THE ISSUES; AS REPORTED; WAS NOT CONFIRMED. HOWEVER, THE RETURNED SHOULDER PACK HAD A BROKEN OFF SHOULDER SNAP HOOK. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE REPORTED EVENT, OF CRACKED DISPLAY WINDOW AND TORN SHOULDER PACK, COULD NOT BE CONFIRMED. THE SHOULDER PACK WAS VISUALLY INSPECTED FOR ANY ANOMALIES AND THE ISSUES. THE RETURNED SHOULDER PACK HAD A BROKEN OFF SHOULDER STRAP CLIP. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SHOULDER PACK WAS TORN AND THE DISPLAY WINDOW WAS CRACKED. THE SHOULDER PACK WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217342 HEARTWARE VENTRICULAR ASSIST SYSTEM - SHOULDER PACK VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 2060 896450

    Patients

    Seq Age Sex Outcome Treatment
    1 MCS UNKNOWN VAD| MCS UNKNOWN VAD