BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE GOGEAR SHOWER BAG

    MDR report key: 9494875 · Received December 19, 2019

    Report

    Report Number
    2916596-2019-05722
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    December 2, 2019
    Report Date
    March 25, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011149
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF DAMAGE COULD NOT BE CONFIRMED. THE ACCOUNT REPORTED THAT THE PATIENT¿S SHOWER BAG HAD A HOLE. THE PATIENT WAS SHOWERING AND THEIR BATTERIES GOT WET. THE PATIENT¿S SHOWER BAG WAS REPLACED AT THEIR APPOINTMENT ON (B)(6) 2019. THE HOSPITAL REQUESTED A REPLACEMENT. MULTIPLE REQUESTS FOR ADDITIONAL INFORMATION REGARDING THE PRODUCT¿S RETURN WERE SENT TO THE CUSTOMER; HOWEVER, NO ADDITIONAL INFORMATION WAS RECEIVED. NO PRODUCT WAS AVAILABLE FOR INVESTIGATION. THE HMII IFU AND PATIENT HANDBOOK STATE THAT ALL WEAR AND CARRY ACCESSORIES SHOULD BE INSPECTED PERIODICALLY DURING USE. IF AN ACCESSORY APPEARS DAMAGED OR WORN, DO NOT USE IT AND CALL YOUR HOSPITAL CONTACT FOR A REPLACEMENT. FURTHERMORE, THE HM SHOWER BAG IFU STATES THAT THE SYSTEM CONTROLLER OR BATTERIES SHOULD NEVER BE EXPOSED TO WATER. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED. PMA/510(K) #: P060040; P160054. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HOLE IN THE SHOWER BAG. PATIENT WAS SHOWERING AND HIS BATTERIES GOT WET. THE SHOWER BAG WAS REPLACED AT THE APPOINTMENT (B)(6) 2019; THE HOSPITAL REQUESTED TO REPLACE THEIR SHELF STOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1288454 HEARTMATE GOGEAR SHOWER BAG VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 104232 6940970 00813024011149

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention