BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1133042 · Received August 22, 2008

    Report

    Report Number
    2031642-2008-00185
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE PERFORMING SERVICE OF THE VENTILATOR, THE MANUFACTURER'S SERVICE TECHNICIAN REPORTED THE POWER FAIL ALARM DID NOT ALARM WHEN THE UNIT WAS ACCIDENTLY UNPLUGGED FROM AC POWER WHILE POWERED ON. THE CUSTOMER DID NOT REPORT ANY SIMILAR FINDING DURING PREVIOUS USAGE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. THE SERVICE TECHNICIAN REPORTED THE VENTILATOR HAD PASSED ALARM TESTS DURING EXTENDED SELF TESTING (EST), AND WAS UNABLE TO AGAIN REPRODUCE THE ABSENCE OF THE ALARM AT LOSS OF AC POWER WHILE POWERED ON. ALL FOLLOW-UP ALARM TESTING PASSED AND THE POWER FAIL ALARMED EACH TIME THE VENTILATOR AC POWER WAS REMOVED WHILE POWERED ON. THE SERVICE TECHNICIAN REPLACED THE BACKUP ALARM AS A PRECAUTION. FINAL TESTING WAS COMPLETED AND ALL APPLICABLE TESTS PASSED PER OPERATING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK RESPIRONICS CALIFORNIA, INC. V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA