BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTOSV ADV SYSTEM ONE

    MDR report key: 13842076 · Received March 21, 2022

    Report

    Report Number
    2518422-2022-10234
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    December 10, 2013
    Report Date
    April 18, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 HOSPITALIZATION - INITIAL OR PROLONGED, REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE, OCCURED IN SECTION B2. AFTER REVIEW, IT WAS DETERMINED THAT THIS OPTIONS WERE INCORRECTLY SELECTED IN SECTION B2. NOTHING SUCH HAS OCCURED TO THE PATIENT. THE REPORT SHOULD HAVE BEEN SENT FOR PRODUCT PROBLEM ONLY IN SECTION B1. IN H6 TYPE OF INVESTIGATION CODE WAS MISSING. THE MISSING VALUE IS 10. IN G4 SECTION PMA/510(K) NUMBER WAS INCORRECT THE CORRECT VALUE IS K090539.

    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
    1974423 BIPAP AUTOSV ADV SYSTEM ONE VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. 951P
    50493 BIPAP AUTOSV ADV SYSTEM ONE VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. 951P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R