BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V60 VENTILATOR

    MDR report key: 11022847 · Received December 16, 2020

    Report

    Report Number
    2031642-2020-04598
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Report Date
    November 22, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, INC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT BEING USED FOR MEDICAL TREATMENT; NO FURTHER DETAILS WERE PROVIDED REGARDING THE EVENT. NO PATIENT OR USER HARM WAS REPORTED.

    Additional Manufacturer Narrative · 0

    THE UNIT WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO PATIENT OR USER HARM REPORTED. CUSTOMER REPORTED A CODE OF 1104-BACKUP ALARM FAILED. DURING TECHNICAL ASSISTANCE, THE REMOTE SERVICE ENGINEER (RSE) VERIFIED WITH CUSTOMER THAT THE FOLLOWING CODES WERE LOGGED (CODES 1101-VENTILATOR RESTARTED DUE TO ANOMALIES DETECTED DURING OPERATION, 1104-BACKUP ALARM FAILED, 111B-35V SUPPLY FAILED, 1115-AUXILLIARY ALARM SUPPLY FAILED). THE CUSTOMER WAS THEN ADVISED TO REPLACE THE CPU BOARD (P/N 1123932 / 453561535741 (SOFTWARE 2.10)). THE RSE ALSO SPOKE WITH THE CUSTOMER REGARDING THE SERIAL NUMBER AND POWER ON HRS RELOAD, WHILE USING A TERATERM. IT WAS ALSO NOTED THAT THE RSE WAS ADVISED TO CALL BACK FOR OPTION CODES. IT WAS REPORTED THAT THE CPU BOARD WAS REPLACED, AND THE CUSTOMER WAS PROVIDED WITH OPTION CODES FOR CFLEX, AVAPS, AND RAMP. MULTIPLE GOOD FAITH EFFORTS (GFE) WERE PERFORMED TO OBTAIN INFORMATION REGARDING THE THE OPERATIONAL STATUS OF THE DEVICE; HOWEVER, NO RESPONSE WAS PROVIDED.

    Additional Manufacturer Narrative · 0

    H11:H6: PATIENT INFORMATION: THE DEVICE WAS BEING USED FOR MEDICAL TREATMENT; NO FURTHER DETAILS WERE PROVIDED REGARDING THE EVENT. NO PATIENT OR USER HARM WAS REPORTED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS BEING USED FOR MEDICAL TREATMENT, AND THE PATIENT WAS TRANSFERRED TO A DIFFERENT VENTILATOR; NO FURTHER DETAILS WERE PROVIDED REGARDING THE EVENT. NO PATIENT OR USER HARM WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: (B)(6) 2020. (B)(6)2020. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FOLLOWING ERRORS: 35 V FAULT, VENTILATOR RESTARTED DUE TO ANOMALIES DETECTED DURING OPERATION, BACKUP ALARM FAILED, 35 V SUPPLY FAILED, AND AUXILIARY ALARM SUPPLY FAILED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484236 V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE MNT RESPIRONICS CALIFORNIA, INC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown