BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRONICS

    MDR report key: 11789491 · Received May 7, 2021

    Report

    Report Number
    2031642-2021-03633
    Event Type
    Injury
    Date Received
    May 7, 2021
    Date of Event
    April 8, 2021
    Manufacturer
    RESPIRONICS CALIFORNIA, LLC
    Product Code
    MNT
    UDI-DI
    00884838025776
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERVICE ENGINEER (SE) EVALUATED AND CONCLUDED THAT THE UNIT DID NOT FAIL TO MEET SPECIFICATIONS. DURING THE DEVICE EVALUATION, THE SE FOUND THAT THE MASK WAS TOO TIGHT AND THE AIR LEAKAGE WAS TOO SMALL. PROBLEM GOT RESOLVED BY ADJUSTING THE MASK . NO REPAIR WAS NEEDED. SE REPORTED THAT DEVICE WAS GOOD TO USE. ROOT CAUSE WAS IMPROPER MASK SETTING. UPON INTERNAL REVIEW, THIS COMPLAINT HAS BEEN UPGRADED FROM A PRODUCT PROBLEM TO A SERIOUS INJURY. THE EVENT OF ELEVATED CARBON DIOXIDE HAS BEEN ASSESSED AS A SEVERITY 2 SERIOUS INJURY THAT NECESSITATED MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY. BASED ON THE INFORMATION PROVIDED, THERE WAS NO DEVICE MALFUNCTION BUT RATHER UNINTENTIONAL USE ERROR FROM TIGHT APPLICATION OF THE MASK IN WHICH THE ISSUE RESOLVED WHEN THE MASK WAS ADJUSTED.

    Additional Manufacturer Narrative · 1

    DATE OF REPORT: 06MAY2021. THE DEVICE WAS REPORTED AS BEING IN USE AT THE TIME OF THE EVENT ON A PATIENT. THERE WAS NO ADVERSE PATIENT IMPACT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE HAD ELEVATED CARBON DIOXIDE. THE DEVICE WAS REPORTED AS BEING IN USE AT THE TIME OF THE EVENT ON A PATIENT. THERE WAS NO ADVERSE PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686833 RESPIRONICS VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE MNT RESPIRONICS CALIFORNIA, LLC V60 VENT, CHINA OPT: CFLEX, AVAPS 00884838025776

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention