BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9642810 · Received January 29, 2020

    Report

    Report Number
    2916596-2020-00183
    Event Type
    Malfunction
    Date Received
    January 29, 2020
    Date of Event
    December 29, 2019
    Report Date
    April 8, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A LOSS OF EXTERNAL POWER WAS CONFIRMED VIA ANALYSIS OF THE SUBMITTED LOG FILES. THE SUBMITTED PERIODIC LOG FILE CONTAINED APPROXIMATELY 11 DAYS OF DATA FROM (B)(6) 2019 TO (B)(6) 2020 PER THE TIMESTAMP. THE LOG FILE CAPTURED AN INCREASE IN THE BACKUP BATTERY USE COUNT FROM 11 TO 12 BETWEEN 6:21:11 AND 7:21:11 ON (B)(6) 2019. THIS INCREASE IN THE BACKUP BATTERY USE COUNT INDICATES THAT A LOSS OF EXTERNAL POWER OCCURRED AND THE BACKUP BATTERY ACTIVATED TO SUPPLY POWER TO THE SYSTEM. A MOMENTARY LOSS OF EXTERNAL POWER WHILE CONNECTED TO THE MPU WOULD RESULT IN THE REPORTED LOW VOLTAGE ALARMS. THE SUBMITTED EVENT LOG FILE CONTAINED APPROXIMATELY 7 DAYS OF DATA FROM (B)(6) 2020 TO (B)(6) 2020. THE EVENT LOG FILE DID NOT CAPTURE DATA FROM THE DATE OF THE REPORTED EVENT ((B)(6) 2019) AS IT WAS OVERWRITTEN BY NEWER DATA. NO NOTABLE ALARMS WERE CAPTURED IN THE LOG FILES. THE PUMP MAINTAINED A SPEED ABOVE OR EQUAL TO THE LOW SPEED LIMIT THROUGHOUT THE LOG FILES. THE ACCOUNT COMMUNICATED THAT THE CAUSE OF THE LOSS OF POWER IS UNKNOWN. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THE MPU WAS SHIPPED WITH A V-LOCK AC POWER CORD. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    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 THE PATIENT HAD TWO LOW VOLTAGE ALARMS NOTED ON CONTROLLER HISTORY FROM (B)(6) 2019 WHEN PATIENT STATED THEY WERE CONNECTED TO WALL POWER. THE PATIENT THOUGHT IT WAS WHILE THEY WERE CONNECTED TO WALL POWER DURING A MOMENTARY LOSS OF POWER. NO SUBSEQUENT ALARMS NOTED. UNFORTUNATELY THE EVENT LOG ONLY GOES BACK TO (B)(6) 2020 SO THE MANUFACTURER TECHNICAL ANALYST CANNOT COMMENT ON THE EVENTS ON (B)(6) 2019, IF THERE WAS A LOSS OF POWER TO THE HOME OR EVEN JUST THE MPU THAT WOULD DEFINITELY CAUSE LOW VOLTAGE EVENTS. NO FURTHER OR ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105632 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR