BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 18535905 · Received January 18, 2024

    Report

    Report Number
    2518422-2024-03273
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    December 22, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A DREAMSTATION AUTO CPAP 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 ALONG WITH CONNECTOR OXIDE CONTAMINATION. DURING TECHNICAL INVESTIGATIONS SIX ERROR CODES WERE FOUND, ERROR CODE 153, 270, 193, 200, 130 AND 56 RESPECTIVELY. 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.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION REGARDING A DREAMSTATION AUTO CPAP. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. DURING VISUAL INSPECTION OF THE DEVICE, CORROSION WAS FOUND ON THE POWER CONNECTOR. IN ADDITION, THE INSPECTION FOUND CONNECTOR OXIDE IN THE DEVICE. THE DEVICE WAS SCRAPPED. THIS REPORT IS BEING SUBMITTED FOR THE CORROSION FOUND ON THE POWER CONNECTOR DURING SERVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759110 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown