BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 13957182 · Received March 30, 2022

    Report

    Report Number
    2518422-2022-06859
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    February 5, 2020
    Report Date
    July 12, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 IN OUTCOMES ATTRIBUTED TO ADVERSE EVENT CONGENITAL ANOMALY/BIRTH DEFECT, BRAND NAME WAS REPORTED AS DREAMSTATION BIPAP , IT WAS REPORTED COMMON DEVICE NAME AS VENTILATOR, NON-CONTINUOUS(RESPIRATOR) AND PRODUCT CODE WAS REPORTED AS BZD AND PMA/ 510(K) NUMBER WAS REPORTED AS K131982 . AFTER REVIEW, IT WAS DETERMINED NO CONGENITAL ANOMALY/BIRTH DEFECT WAS REPORTED ,THIS WAS INCORRECTLY MARKED IN OUTCOMES ATTRIBUTED TO ADVERSE EVENT. BRAND NAME WAS INCORRECTLY REPORTED AS DREAMSTATION BIPAP ., INCORRECTLY REPORTED COMMON DEVICE NAME AS VENTILATOR,NON-CONTINUOUS(RESPIRATOR) AND PRODUCT CODE WAS INCORRECTLY REPORTED AS BZD AND INCORRECTLY PMA/ 510(K) NUMBER WAS REPORTED AS K131982. THE REPORT SHOULD HAVE BEEN SENT FOR PRODUCT PROBLEM ONLY IN ADVERSE EVENT OR PRODUCT PROBLEM. BRAND NAME WAS TAKEN AS DREAMSTATION BIPAP AUTOSV . DEVICE NAME WAS TAKEN AS VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING . AND PRODUCT CODE WAS TAKEN AS MNS. PMA/ 510(K) NUMBER WAS TAKEN AS K090539. ADDRESS WAS UPDATED. 'EVALUATION SUMMARY ATTACHED' WAS UN MARKED IN DEVICE EVALUATED BY MFR.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING AN UPDATED REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, A FOLLOW-UP REPORT WILL BE FILED.

    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 ALLEGATION OF 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
    786883 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900H11
    843347 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900H11

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Congenital Anomaly