BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9363703 · Received November 22, 2019

    Report

    Report Number
    2916596-2019-05268
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    November 1, 2019
    Report Date
    March 24, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION G4: ADDITIONAL INFORMATION MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF NO EXTERNAL POWER ALARM WAS CONFIRMED WITH THE LOG FILE SUBMITTED ON (B)(6), 2019. THE LOG FILE CAPTURED NO EXTERNAL POWER ALARM EVENTS ON NOVEMBER 1 AND 5. ON NOVEMBER 1, THE SYSTEM WAS CONNECTED TO THE MOBILE POWER UNIT. ACCORDING TO THE VOLTAGE VALUES, THERE WAS A LOSS OF POWER FROM THE MOBILE POWER UNIT AT 10:29 PM. ON NOVEMBER 5, THE BLACK POWER CABLE WAS DISCONNECTED FROM THE 14V BATTERY/CLIP AT 9:17 PM. THE FOLLOWING EVENT CAPTURED THE WHITE POWER CABLE WAS DISCONNECTED, WHICH RESULTED IN THE NO EXTERNAL POWER ALARM. THIS EVENT INDICATES A DOUBLE POWER CABLE DISCONNECTION. ATTEMPT WAS MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. ALL AVAILABLE INFORMATION FOR CONDUCTING THIS INVESTIGATION WAS COLLECTED AND NO ADDITIONAL FOLLOW-UP ATTEMPTS WILL BE PERFORMED. TO DATE, THE MOBILE POWER UNIT (SERIAL # UNAVAILABLE) ASSOCIATED WITH THE EVENT WAS UNAVAILABLE FOR AN EVALUATION. THE COMPLAINT FILE WILL CLOSE ACCORDINGLY AND WILL BE REOPENED IF PERTINENT INFORMATION IS RECEIVED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER WAS REQUESTED, BUT NOT PROVIDED. 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 WAS ADMITTED TO (B)(6) HOSPITAL (SFH) FROM ANOTHER FACILITY. DURING INTERROGATION, IT WAS NOTED THAT THE PATIENT HAD NO EXTERNAL POWER ALARMS ON (B)(6) 2019 AND ABOUT 3 TO 4 NO EXTERNAL POWER ALARMS ON (B)(6) 2019. PATIENT WAS CONFUSED AND WAS NOT ABLE TO VERBALIZE ANY POWER LOSS OR RECALL THE OCCURRENCE. PATIENT HAD MULTIPLE LOW VOLTAGE ADVISORIES IN THE MONTH OF (B)(6) AS WELL. THE LOG FILE ANALYSIS SHOWED THAT THERE WERE CAPTURED LOW FLOW EVENTS ON (B)(6) 2019. THERE WAS NO TYPE OF MCS EQUIPMENT ISSUES CAUSING THESE EVENTS. THE LOW FLOW EVENTS SEEMED TO BE A PATIENT RELATED ISSUE AND NOT AN EQUIPMENT RELATED ISSUE. THE LOG FILE CAPTURED A NO EXTERNAL POWER EVENT ON (B)(6) 2019. A NO EXTERNAL POWER EVENT WAS CAPTURED ON (B)(6) 2019 DUE TO SIMULTANEOUS POWER LEAD DISCONNECTS WHILE THE PATIENT WAS SWITCHING POWER SOURCES. THERE WERE NO OTHER UNUSUAL EVENTS RECORDED IN THE LOG FILE. THE MCS EQUIPMENT WAS OPERATING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160574 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization