BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORMA 100

    MDR report key: 13777433 · Received March 16, 2022

    Report

    Report Number
    2518422-2022-09482
    Event Type
    Malfunction
    Date Received
    March 16, 2022
    Date of Event
    October 11, 2016
    Report Date
    April 18, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K130077
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    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 REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE, OCCURED IN OUTCOMES ATTRIBUTED TO ADVERSE EVENT. AFTER REVIEW, IT WAS DETERMINED THAT THIS OPTIONS WERE INCORRECTLY SELECTED IN OUTCOMES ATTRIBUTED TO ADVERSE EVENT. NOTHING SUCH HAS OCCURED TO THE PATIENT. THE REPORT SHOULD HAVE BEEN SENT FOR PRODUCT PROBLEM ONLY IN ADVERSE EVENT OR PRODUCT PROBLEM. PMA/510(K) NUMBER WAS INCORRECT THE CORRECT VALUE IS K130077.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE MANUFACTURER RECEIVED INFORMATION ALLEGING BLACK PARTICLES IN BIPAP DEVICE. 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
    674982 DORMA 100 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 751P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention