BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 9930915 · Received April 6, 2020

    Report

    Report Number
    2031642-2020-01190
    Event Type
    Malfunction
    Date Received
    April 6, 2020
    Report Date
    March 17, 2020
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 09JUL2020 B4: (B)(6)2020 THE VENTILATOR'S POWER SUPPLY WAS RETURNED TO THE MANUFACTURER'S FAILURE INVESTIGATION LAB FOR EVALUATION. VISUAL INSPECTION OF THE POWER SUPPLY REVEALED NO EVIDENCE OF DAMAGE AND CONTAMINATION. THE POWER SUPPLY WAS INSTALLED INTO THE FAILURE INVESTIGATION (FI) TEST VENTILATOR TO VERIFY & TEST ITS FUNCTIONAL INTEGRITY. FROM TESTING, IT WAS DETERMINED THAT THE TEST VENTILATOR UTILIZED WITH THE RETURNED POWER SUPPLY DID NOT PASS TESTING. THE VENTILATOR SHUT DOWN WHEN ALTERNATING CURRENT (POWER FROM THE POWER SUPPLY) WAS APPLIED. FURTHER TESTING DETERMINED VOLTAGE WAS DROPPING BELOW THE THRESHOLD VOLTAGE OF 8.5 VOLTS, AND THE "C56" CAPACITOR SIGNAL WAS DROPPING TO 7.11VOLTS. THE FAILURE OF THE CAPACITOR "C56" OF THE POWER SUPPLY PREVENTED THE VENTILATOR FROM OPERATING ON AC POWER. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 0

    G4: 27MAR2020. B4: 14APR2020. THERE WAS NO PATIENT INVOLVEMENT AND NO ALLEGATION OF HARM ASSOCIATED WITH THIS REPORT. THE MANUFACTURER'S FIELD SERVICE ENGINEER (FSE) CONFIRMED THE REPORTED PROBLEM. THE FSE ALSO HEARD CLICKING FROM THE POWER SUPPLY, AS WELL AS BUS VOLTAGE MOVING BETWEEN 29 AND 21 VOLTS. THE FSE REPLACED THE BACKUP BATTERY TO ADDRESS AND CORRECT THIS REPORTED CONDITION. THE FSE ALSO REPLACED THE POWER SUPPLY TO ADDRESS THE VOLT VARIANCE AND CLICKING. THE DEVICE THEN PASSED ALL SPECIFICATIONS. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. DATE OF REPORT: 06APR2020.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENT BACKUP BATTERY AND THE EXTERNAL BATTERY ARE NOT FUNCTIONING. THE VENT WILL NOT WORK WITHOUT THE BATTERIES WORKING. IT IS UNKNOWN IF THE VENTILATOR WAS BEING USED ON A PATIENT AT THE TIME THAT THE ERROR WAS DISCOVERED. CONFIRMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392979 ESPRIT VENTILATOR VENTILATOR CBK RESPIRONICS CALIFORNIA, INC V1000

    Patients

    Seq Age Sex Outcome Treatment
    1