BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTOSV ADV

    MDR report key: 13719737 · Received March 10, 2022

    Report

    Report Number
    2518422-2022-09257
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    February 27, 2020
    Report Date
    April 18, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959031975
    PMA / PMN Number
    K090248
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 HOSPITALIZATION - INITIAL OR PROLONGED IN B.2 SECTION, WHICH WAS MARKED INCORRECTLY AS THIS IS PRODUCT PROBLEM ONLY AS MENTIONED IN B.1 SECTION IN PREVIOUS REPORT . IN SECTION B5 INCORRECT DESCRIPTION OF EVENT OR PRODUCT PROBLEM WAS REPORTED WHICH IS CORRECTLY UPDATED IN THIS FOLLOW UP REPORT.IN SECTION D2 PRODUCT CODE IS INCORRECTLY REPORTED AS BZD WHICH IS NOW UPDATED AS MNS AND COMMON DEVICE NAME IS CHANGE ACCORDINGLY. G.2 SECTION INCORRECTLY MARK ON HEALTH PROFESSIONAL THE PREVIOUS REPORT, IN THIS CORRECTION REPORT IT IS CORRECTLY MARKED AS FOREIGN . IN G4 SECTION PMA/510(K) NO WAS REPORTED AS K091319 WHICH IS UPDATED AS K090248 IN THIS FOLLOW UP REPORT. IN G6 SECTION '15 DAY' SHOULD BE UNMARKED. H.3 SECTION INCORRECTLY REPORTED AS YES IN THE PREVIOUS REPORT, WHICH IS CORRECTLY REPORTED AS NO IN THIS FOLLOW UP REPORT.

    Description of Event or Problem · 0

    A VENTILATOR WAS RETURNED FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION AT THE MANUFACTURER'S SERVICE CENTER, THE SOUND ABATEMENT FOAM WAS REPLACED FOR REPAIR. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Description of Event or Problem · 0

    A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER, THE DEVICE'S SOUND ABATEMENT FOAM WAS REPLACED. 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
    1974409 BIPAP AUTOSV ADV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. 961P 00606959031975
    2452412 BIPAP AUTOSV ADV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. 961P 00606959031975

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization