BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 8302580 · Received February 4, 2019

    Report

    Report Number
    2916596-2019-00546
    Event Type
    Malfunction
    Date Received
    February 4, 2019
    Date of Event
    January 15, 2019
    Report Date
    April 26, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE REPORTED EVENT OF A NO EXTERNAL POWER ALARM WAS CONFIRMED BASED ON THE INFORMATION RECORDED IN THE LOG FILE PROVIDED BY THE CUSTOMER. THE LOG FILE CONTAINED EVENTS RECORDED FROM (B)(6) 2019 TO (B)(6) 2019. THE INFORMATION RECORDED ON 15JAN2019 AT 04:27 PM REVEALED THAT THE SYSTEM WAS POWERED BY A MPU AND THE POWER TO THE MPU WAS LOST RESULTING IN LOW POWER HAZARD AND NO EXTERNAL POWER ALARMS. THE MPU POWER WAS RESTORED AND THE ALARMS CLEARED. THE PUMP SUPPORT WAS NOT AFFECTED, AND THE SYSTEM WAS SUPPORTED BY THE BACKUP BATTERY DURING THE EVENT. THERE WERE NO OTHER UNUSUAL EVENTS NOTED WITHIN THE LOG FILE. ACCORDING TO THE ADDITIONAL INFORMATION, THE EVENT WAS RELATED TO THE MPU BEING ACCIDENTLY DISCONNECTED FROM THE WALL AND NOT RELATED TO A MALFUNCTION OF THE EQUIPMENT. THE MPU WAS NOT RETURNED FOR EVALUATION AND REMAINED IN USE. AS A RESULT, THE COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTIONS. THE DEVICE HISTORY RECORDS WERE REVIEWED (SHOP ORDERS 183472 AND 182653) AND THE RECORDS REVEALED THE MPU WAS MANUFACTURED IN ACCORDANCE WITH MFG AND QA SPECIFICATIONS. (B)(4) WAS SHIPPED TO THE CUSTOMER ON 10/28/2016 IN CUSTOMER ORDER S185439. REVIEW OF THE DHR'S NOTED THAT THE MPU WAS MANUFACTURED WITH THE V-LOCK AC CONNECTOR (PART NUMBER: 10001077 (REV. A), LOT# 20161794). THE MANUFACTURER IS CLOSING THE FILE ON THE EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: THE PLUG CAME LOOSE FROM THE WALL NOT FROM THE BACK OF MOBILE POWER UNIT (MPU). THIS EVENT HAS NOT RECURRED.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE - 2 YEARS. THE PATIENT REMAINS ONGOING WITH THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2016. IT WAS REPORTED THERE WAS A LOSS OF POWER TO THE MOBILE POWER UNIT. THE SYSTEM CONTINUED TO OPERATE AT THE SET SPEED, AND WAS SUPPORTED BY THE CONTROLLER¿S BACKUP BATTERY UNTIL EXTERNAL POWER WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93807 HEARTMATE MOBILE POWER UNIT, NA MOBILE POWER UNIT DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR