BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC

    MDR report key: 275282 · Received April 17, 2000

    Report

    Report Number
    MW4002735
    Event Type
    Injury
    Date Received
    April 17, 2000
    Date of Event
    April 29, 1997
    Report Date
    May 28, 1997
    Manufacturer
    THORATEC LABORATORIES CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    MALFUNCTION OF UNIVERSAL POWER SUPPLY. AFTER APPROX 3-4 MINUTES OF OPERATION, UPS STOPPED SUPPLYING POWER WITHOUT WARNING. UPS HAD BEEN CHARGED FOR MORE THAN 24 HOURS. THIS DID CAUSE THE THORATEC VADS TO STOP FOR A VERY SHORT TIME. THERE WAS NO KNOWN INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC VAD CONSOLE (DUAL DRIVE CONSOLE) DSQ THORATEC LABORATORIES CORP. 2600 *

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Life Threatening