BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP ST

    MDR report key: 13661256 · Received March 3, 2022

    Report

    Report Number
    2518422-2022-07753
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    May 31, 2019
    Report Date
    April 14, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959030572
    PMA / PMN Number
    K102465
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A BATCH SUBMISSION OF COMPLAINTS THAT WERE REASSESSED AS REPORTABLE FOAM DEGRADATION COMPLAINTS; DISCOVERED AS PART OF A RETROSPECTIVE REMEDIATION REVIEW.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THAT REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE, OCCURED IN SECTION B2. AFTER REVIEW, IT WAS DETERMINED THAT THIS OPTION WAS INCORRECTLY SELECTED IN SECTION B2. NOTHING SUCH HAS OCCURED TO THE PATIENT. IN G4 SECTION PMA/510(K) NUMBER WAS INCORRECT THE CORRECT VALUE IS K102465. THE REPORT SHOULD HAVE BEEN SENT FOR PRODUCT PROBLEM ONLY IN SECTION B1. IN D4 THERE IS NO UDI NUMBER. AND E1 AND D2 ARE UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167523 BIPAP ST VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. 1061402 00606959030572
    786824 BIPAP ST VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. 1061402 00606959030572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention