BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION CPAP PRO

    MDR report key: 13934288 · Received March 28, 2022

    Report

    Report Number
    2518422-2022-11072
    Event Type
    Malfunction
    Date Received
    March 28, 2022
    Date of Event
    December 9, 2019
    Report Date
    October 25, 2023
    Manufacturer
    RESPIRONICS, INC
    Product Code
    BZD
    UDI-DI
    00606959034518
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 INCORRECT INFORMATION ALLEGING AN ISSUE RELATED TO THE CPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND PARTICLE CONTAMINATION ON TOP AND BOTTOM ENCLOSURES AND REAR PANEL - BLACK DIRT/DUST WAS OBSERVED DURING DEVICE EVALUATION. 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. SECTION B5 SHOULD HAVE BEEN REPORTED AS: A CPAP WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO PATIENT HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, PARTICLE CONTAMINATION WAS OBSERVED IN THE IN TOP AND BOTTOM ENCLOSURES. THE UNIT WAS SCRAPPED. SECTION E. 1 WAS INCORRECTLY REPORTED IN PREVIOUS REPORT, WHICH IS NOW UPDATED IN THIS FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2022-11072-1 WITH INCORRECT INFORMATION IN SECTION B2 AS DEATH. AFTER REVIEW, IT WAS DETERMINED THAT THIS WAS INCORRECTLY SELECTED IN SECTION B2. NOTHING SUCH HAS OCCURED TO THE PATIENT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO THE CPAP DEVICE'S SOUND ABATEMENT FOAM. THE DEVICE WAS RETURNED AND PARTICLE CONTAMINATION ON TOP AND BOTTOM ENCLOSURES AND REAR PANEL - BLACK DIRT/DUST WAS OBSERVED DURING DEVICE EVALUATION. 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
    32597 DREAMSTATION CPAP PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC CAX400T12C 00606959034518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death