BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNILAB ADVANCED PLUS

    MDR report key: 13961713 · Received March 31, 2022

    Report

    Report Number
    2518422-2022-05370
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    August 4, 2021
    Report Date
    July 12, 2022
    Manufacturer
    RESPIRONICS, INC
    Product Code
    MNS
    UDI-DI
    00606959029392
    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 MARKED H10 INCORRECTLY. THIS MDR WAS NOT 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 D9 REPORTED AS DEVICE AVAILABLE FOR EVALUATION, IN SECTION H.3. IT WAS MARKED IN EVALUATION SUMMARY ATTACHED, 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 SECTION D9 INCORRECTLY REPORTED AS DEVICE AVAILABLE FOR EVALUATION, IN SECTION H.3 INCORRECTLY MARKED ON 'EVALUATION SUMMARY ATTACHED'., IN D2 INCORRECTLY REPORTED COMMON DEVICE NAME AS VENTILATOR, NON-CONTINUOUS(RESPIRATOR) AND PRODUCT CODE WAS INCORRECTLY REPORTED AS BZD AND MISTAKENLY IN G4, PMA/ 510(K) NUMBER WAS REPORTED AS K131982. THE REPORT SHOULD HAVE BEEN SENT FOR PRODUCT PROBLEM ONLY IN SECTION B.1. D9 MARKED AS NO, SECTION H3 WAS MARKED AS NO AND EVALUATION SUMMARY WAS UNCKECKED . IN D2 DEVICE NAME WAS TAKEN AS VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING . AND PRODUCT CODE WAS TAKEN AS MNS. IN E1 ZIP CODE WAS UPDATED AS 80239-2729. IN G4, PMA/ 510(K) NUMBER WAS TAKEN AS K090539.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP 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
    1391316 OMNILAB ADVANCED PLUS VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC 1111123 00606959029392
    786886 OMNILAB ADVANCED PLUS VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC 1111123 00606959029392

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Congenital Anomaly