BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 15731491 · Received November 4, 2022

    Report

    Report Number
    2031642-2022-02736
    Event Type
    Malfunction
    Date Received
    November 4, 2022
    Date of Event
    August 31, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS IN USE ON A PATIENT AT THE TIME THE REPORTED ISSUE WAS DISCOVERED; HOWEVER, THERE WAS NO HARM TO THE PATIENT OR USER. THE DEVICE WAS SWAPPED OUT WITH A DIFFERENT DEVICE. NO MEDICAL INTERVENTION PROVIDED TO THE PATIENT NOR A DELAY WAS NOTED. THE BIOMEDICAL ENGINEER AT THE HOSPITAL CHECKED THE INLET FILTER AFTER THE INCIDENT AND CONTACTED VINGMED AB-SERVICE. VINGMED-SERVICE ASKED FOR THE TIME OF EVENT AND LOGS. AFTER THIS WE RECOMMENDED THAT THE END-CUSTOMER EXCHANGE THE O2-VALVE AND THE DATA ACQUISITION PCBA. AFTER FURTHER INVESTIGATION THE REPORTED PROBLEM HAS NOT BEEN REPRODUCED. THE DEVICE WAS NOT REPAIRED. IT WAS TAKEN OUT OF USE AFTER THE INCIDENT. NO PARTS WERE REPLACED, THE CUSTOMER HAS DECIDED TO SCRAP THIS VENTILATOR AS IT IS OLD. TOO EXPENSIVE TO REPAIR. NO ADDITIONAL DETAILS REGARDING THE REPORTED ISSUE. THE DEFECTIVE UNIT WILL BE SCRAPPED. IF THE DECISION IS MADE TO HAVE THE DEVICE EVALUATED AND REPAIRED A NEW SERVICE ORDER WILL BE OPENED AND WILL BE CAPTURED THROUGH PHILIP'S NORMAL COMPLAINT PROCEDURE.

    Additional Manufacturer Narrative · 0

    REPORTING ADDRESS STATE: (B)(6). THE MANUFACTURER STILL NEEDS TO COMPLETE THE INVESTIGATION OF THIS EVENT. AN UPDATED REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE ALARM COMES UP AFTER A WHILE WHEN THE VENTILATOR IS SET FROM 21 TO 22 % OF OXYGEN. IT IS UNKNOWN IF THERE'S PATIENT INVOLVEMENT. ALARM DESCRIPTION: "1111, 07:58.32AM, (B)(6) 2022, CBITO2 DEVICE FAILED". THIS VENTILATOR HAD A SIMILAR ERROR IN 2016, AND AT THAT TIME, THE RP-SOLENOID VALVE WAS EXCHANGED, AND THE PROBLEM DID NOT REOCCUR AFTER A DISCUSSION WITH THE END CUSTOMER. IT WAS DECIDED TO EXCHANGE THE VALVE AGAIN AND THE DATA ACQUISITION TO BE SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522461 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown