BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP AVAPS

    MDR report key: 13594748 · Received February 24, 2022

    Report

    Report Number
    2518422-2022-06000
    Event Type
    Malfunction
    Date Received
    February 24, 2022
    Date of Event
    November 17, 2014
    Report Date
    April 14, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959043985
    PMA / PMN Number
    K102465
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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. A.1 SECTION WAS INORRECT PATIENT INTIAL NAME WAS REPORTED IN THE PREVIOUS REPORT, WHICH CORRECTLY UPDATED IN THIS FOLLOW UP REPORT AS UNKNOWN. G.2 SECTION WAS MISSING THE PREVIOUS REPORT, IN THIS CORRECTION REPORT IT IS CORRECTLY MARKED AS CONSUMER. E.1 SECTION WAS MISSING IN THE PREVIOUS REPORT, WHICH IS CORRECTLY UPDATED IN THIS FOLLOW UP REPORT. D.9 AND H.3 SECTION INCORRECTLY REPORTED AS NO IN THE PREVIOUS REPORT, WHICH IS CORRECTLY REPORTED AS YES IN THIS FOLLOW UP REPORT. H.10 COMMENT WAS MISSING IN PREVIOUS REPORT, THE CORRECT COMMENT IS NOW UPDATED IN FOLLOW UP REPORT AS: 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. TYPE OF INVESTIGATION IN H.6 ALSO MISSED TO MENTION 10(TESTING OF ACTUAL/SUSPECTED DEVICE), WHICH CORRECTLY UPDATED NOW. D.1 AND D.2 SECTIONS WERE WRONGLY REPORTED IN THE PREVIOUS REPORT, WHICH ARE CORRECTLY UPDATED IN THIS FOLLOW UP REPORT. PMA/510(K) NUMBER IN G.4 WRONGLY UPDATED IN PREVIOUS REPORT, WHICH IS CORRECTLY UPDATED AS K102465 IN THIS FOLLOW UP REPORT.

    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
    1091871 DREAMSTATION BIPAP AVAPS VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. 1060657 00606959043985
    969915 DREAMSTATION BIPAP AVAPS VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. 1060657 00606959043985

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization