BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    840 VENTILATOR

    MDR report key: 9689794 · Received February 10, 2020

    Report

    Report Number
    8020893-2020-00020
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Report Date
    February 10, 2020
    Manufacturer
    COVIDIEN
    Product Code
    CBK
    PMA / PMN Number
    K151252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE MEDTRONIC FIELD SERVICE ENGINEER EVALUATED THE VENTILATOR AND REPLACED THE BREATH DELIVERY (BD) PRINTED CIRCUIT BOARD (PCB), PIEZO ALARM, ANALOG INTERFACE (AI) PCB AND THE POWER SUPPLY. THE VENTILATOR PASSED ALL TESTING PER MANUFACTURER SPECIFICATIONS AT THE TIME OF SERVICE AND WAS RETURNED TO THE CUSTOMER. THE FOLLOWING COMPONENTS WERE RETURNED FOR FURTHER ANALYSIS: AI PCB, BD PCB, CONDOR POWER SUPPLY THE AI PCB WAS VISUALLY INSPECTED AND NOTED MULTIPLE COMPONENTS WERE THERMALLY DAMAGED INCLUDING DIODES D58, D59, D60, D62 AND D63. THE PCB WAS NOT INSTALLED IN THE VENTILATOR TO AVOID FURTHER DAMAGE. THE COMPONENT DAMAGE WAS CAUSED BY THE CONDOR POWER SUPPLY WHICH WAS ALSO RETURNED UNDER THIS COMPLAINT NUMBER. THE BD PCB WAS VISUALLY INSPECTED AND THE FOLLOWING WAS OBSERVED: CAPACITOR C100 WAS PHYSICALLY BROKEN OFF THE PCB. THIS WAS NOT THE CAUSE OF THE REPORTED FAULT. THE DAMAGE OCCURRED DUE TO MISHANDLING AT SOME TIME DURING THE 20 YEAR SERVICE LIFE OF THIS PCB. THE REPORTED FAULT WAS CAUSED BY THE CONDOR POWER SUPPLY WHICH WAS ALSO RETURNED UNDER THIS COMPLAINT NUMBER. THE CONDOR POWER SUPPLY WAS RETURNED AND THE FOLLOWING WAS FOUND: THERE WAS AN ODOR OF THERMAL COMPONENT DAMAGE FROM THE UNIT. AN INTERNAL VISUAL INSPECTION REVEALED THAT THE C30 CAPACITOR DEVICE WAS SEVERELY THERMALLY DAMAGED. THE C30 DECOUPLING CAPACITOR IS A 4700 PF, 1KV CERAMIC DEVICE,CONNECTED BETWEEN THE T4 TRANSFORMER AND CHASSIS GROUND. THE DEVICE INITIALLY BROKE DOWN INTERNALLY CAUSING A SHORT CIRCUIT TO CHASSIS GROUND BEFORE IT BURNED UP. THIS CAUSED FURTHER DAMAGE TO OTHER PCBS ON THE VENTILATOR. THE POWER SUPPLY MANUFACTURE DATE: AUGUST 1998. THIS UNIT HAS A SERVICE LIFE OF APPROXIMATELY 20 YEARS. IF THIS FAILURE OCCURRED DURING VENTILATION THE VENTILATOR WOULD GENERATE A VENT INOP CONDITION. THE APPROPRIATE AUDIO AND VISUAL ALARMS WOULD ENUNCIATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 840 VENTILATOR WOULDN'T TURN ON. THE VENTILATOR WAS NOT IN USE ON A PATIENT AT THE TIME OF THE REPORTED EVENT. BASED ON PRODUCT ANALYSIS OF THE POWER SUPPLY, THE POWER SUPPLY WOULD HAVE CAUSED A LOSS OF VENTILATION IF IT WERE TO OCCUR ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148657 840 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK COVIDIEN 4-076028-00

    Patients

    Seq Age Sex Outcome Treatment
    1