BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 18274144 · Received December 6, 2023

    Report

    Report Number
    2518422-2023-33528
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 22, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A DREAMSTATION BIPAP AUTOSV H/HT/C, DS UNIT. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING VISUAL INSPECTION OF THE DEVICE, IT WAS DETERMINED THE POWER CONNECTOR OF THE UNIT WAS CORRODED. DEVICE WAS SCRAPPED AT CUSTOMER'S REQUEST. ANALYSIS OF PAST EVENTS HAS NOT INDICATED AN ADVERSE EVENT HAS OCCURRED DUE TO CORROSION. REVIEW OF THE RISK FILE INDICATES THE POTENTIAL FOR A SERIOUS ADVERSE EVENT OCCURRING AS A RESULT OF THIS INCIDENT IS UNLIKELY. ADDITIONALLY, THE RISK FILE INDICATES THAT CORROSION WILL NOT SUBSTANTIALLY AFFECT THE PERFORMANCE OF THE DEVICE. THIS COMPLAINT IS CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION REGARDING A DREAMSTATION BIPAP AUTOSV. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING VISUAL INSPECTION OF THE DEVICE, CORROSION WAS FOUND IN DEVICE. THIS REPORT IS BEING SUBMITTED FOR THE CORROSION WAS FOUND IN DEVICE DURING SERVICE. THE DEVICE WAS FOUND TO HAVE CONTAMINATION DESCRIBED AS CONNECTOR OXIDE. NO EVIDENCE OF FOAM PARTICLES WAS OBSERVED WITHIN THE DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS SCRAPPED. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1252039 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown