BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 13957287 · Received March 30, 2022

    Report

    Report Number
    2518422-2022-06856
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    January 28, 2020
    Report Date
    April 14, 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
    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 SECTION B.2. CONGENITAL ANOMALY/BIRTH DEFECT,IN SECTION B5 REPORTED THAT THE DEVICE WAS RETURNED AND OBSERVE THERAPY PCA DURING DEVICE EVALUATION, IN SECTION D1 BRAND NAME WAS REPORTED AS DREAMSTATION BIPAP , IN SECTION D2 IT WAS REPORTED COMMON DEVICE NAME AS VENTILATOR, NON-CONTINUOUS(RESPIRATOR) AND PRODUCT CODE WAS REPORTED AS BZD AND IN G4, 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 SECTION B.2.,IN B5 SECTION DURING DEVICE EVALUATION THERAPY PCA WAS INCORRECTLY REPORTED, IN SECTION D1 BRAND NAME WAS INCORRECTLY REPORTED AS DREAMSTATION BIPAP ., IN D2 COMMON DEVICE NAME WAS INCORRECTLY REPORTED AS VENTILATOR,NON-CONTINUOUS(RESPIRATOR) AND PRODUCT CODE WAS INCORRECTLY REPORTED AS BZD AND IN G4 SECTION , PMA/ 510(K) NUMBER WAS INCORRECTLY REPORTED AS K131982. THE REPORT SHOULD HAVE BEEN SENT FOR PRODUCT PROBLEM ONLY IN SECTION B.1. CORRECT COMMENT WAS UPDATED IN B5. IN D1 BRAND NAME WAS TAKEN AS DREAMSTATION BIPAP AUTOSV . IN D2 DEVICE NAME WAS TAKEN AS VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING . AND PRODUCT CODE WAS TAKEN AS MNS. ADDRESS WAS UPDATED IN SECTION E1. IN G4, PMA/ 510(K) NUMBER WAS TAKEN AS K090539. 'EVALUATION SUMMARY ATTACHED' WAS UN MARKED IN SECTION H3.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND OBSERVE THERAPY PCA DURING DEVICE EVALUATION. 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.

    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
    1128682 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC DSX900T11C
    786885 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC DSX900T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Congenital Anomaly