BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRONICS

    MDR report key: 11815456 · Received May 12, 2021

    Report

    Report Number
    2031642-2021-03697
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 14, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838009851
    PMA / PMN Number
    K102985
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OR USER HARM REPORTED. THE CUSTOMER DID CONFIRM THAT A 110A ERROR CODE DID OCCUR. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW-UP WITH THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION. THE CUSTOMER REPORTED THAT THE DATA ACQUISITION (DAQ) BOARD WOULD BE RETURNED FOR ANALYSIS. AS OF 03MAR2022, THE DAQ BOARD HAS NOT BEEN RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENTILATOR EXPERIENCED A PRESSURE SENSOR AUTO ZERO FAILURE. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER (FSE) WHO CONFIRMED THE REPORTED PROBLEM. THE FSE REPLACED THE DATA ACQUISITION BOARD. FOLLOWING THE REPAIR, THE DEVICE WAS REPORTED TO RETURN TO NORMAL TRIAL. NO OTHER ANOMALIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707205 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 00884838009851

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown