BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 14104529 · Received April 13, 2022

    Report

    Report Number
    2031642-2022-00954
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 18, 2022
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838020054
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PER BIOMED HE WAS USING CABLE, REMOTE ALARM, NORMALLY CLOSED (ALARM STATE = OPEN), (15.24 M) (50 FT) P/N 1003741 AND THIS REMOTE ALARM CABLE IS NOT TRIGGERING THE ALARM ON THE VENTILATOR. ADVISED BIOMED TO ORDER -CABLE, REMOTE ALARM, NORMALLY OPEN (ALARM STATE = CLOSED), (15.24 M) (50 FT) P/N 1003742 ,9898056118. PER BIOMED HE WILL ORDER THE CABLE AS INDICATED. NO FURTHER INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 0

    PER THE BIOMEDICAL ENGINEER THEY WERE TESTING THE ALARM CABLES THAT THEY HAD STORED IN THEIR DEPARTMENT. THE CABLES WERE LABELED FOR THE V60. UNFORTUNATELY, THE CABLES DID NOT TRIGGER THE NURSE CALL SYSTEM APPROPRIATELY. THE BIOMEDICAL ENGINEER REPORTED THAT THE CABLES WERE NOT PLACED ON THE UNIT AND WERE NOT UTILIZED AT ALL. THE BIOMEDICAL ENGINEER REPORTED THAT THE CABLES FOR THE NURSE CALL SYSTEMS ARE CURRENTLY ON BACK ORDER. NO FURTHER INFORMATION PROVIDED.

    Description of Event or Problem · 0

    THE CUSTOMER STATES THAT THE UNIT DOES NOT TRIGGER THE NURSE CALL EXCEPT WHEN IT IS FIRST TURNED ON. THE CUSTOMER REPORTED THAT THE UNIT WAS NOT IN USE ON A PATIENT. THE CUSTOMER CONTACTED PRODUCT SUPPORT AND IT WAS DETERMINED THAT THE CUSTOMER HAS A NORMALLY CLOSED CABLE. PRODUCT SUPPORT PROVIDED PART NUMBER FOR NORMALLY OPEN CABLE AND SUGGESTED TO CUSTOMER TO TRY THAT ONE. THE CUSTOMER WILL ORDER CORRECT NURSE CALL CABLE. FURTHER INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2564638 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838020054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown