BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11856961 · Received May 20, 2021

    Report

    Report Number
    2031642-2021-03779
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 20, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    CBK
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS INCORRECTLY REPORTED AS A V60 VENTILATOR. THE DEVICE IS ACTUALLY A V200. G5: 510K - K102054. D2: VENTILATOR, CONTINUOUS, FACILITY USE, MNT. D4: MODEL#: V200. CATALOG#: 1060264. DEVICE IDENTIFIER (GTIN): (B)(4).

    Additional Manufacturer Narrative · 0

    G5: 510(K)#: K102985. B4: 16JUL2021. THE ISSUE WAS DISCOVERED DURING TESTING OUTSIDE OF CLINICAL USE. THERE WAS NO DELAY TO PATIENT THERAPY REPORTED. THE CUSTOMER WAS ATTEMPTING TO REPLACE THE POWER SUPPLY; HOWEVER, THE CUSTOMER HAS DECIDED TO RETIRE THE UNIT DUE TO THE UNIT BEING AT THE END OF LIFE. NO OTHER ANOMALIES WERE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A VENTILATOR EXPERIENCED A VENTILATOR INOPERABLE CONDITION AT POWER ON. THE DEVICE WAS EVALUATED BY THE CUSTOMER AND A REMOTE SERVICE ENGINEER (RSE) WHO CONFIRMED THE REPORTED ISSUE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARM REPORTED. THE RSE ADVISED THE CUSTOMER THAT THE VENTILATOR IS AN END OF LIFE (EOL) UNIT INDICATING THAT THE UNIT IS NO LONGER SERVICED OR SUPPORTED BY PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756111 RESPIRONICS VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, LLC V200 00884838020054
    756112 RESPIRONICS VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS CALIFORNIA, LLC V200 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown