FDA Adverse Event
Malfunction
Summary report: N
REP DREAMSTATION AUTO CPAP
MDR report key: 24600287
·
Received March 14, 2026
Report
- Report Number
- 2518422-2026-009612
- Event Type
- Malfunction
- Date Received
- March 14, 2026
- Date of Event
- March 6, 2026
- Report Date
- April 23, 2026
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- UDI-DI
- 00606959429765
- PMA / PMN Number
- K131982
- Removal / Correction Number
- Z-1974-2021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
UPON REVIEW, IT WAS DETERMINED THIS REPORT IS A DUPLICATE OF MFR 2518422-2025-043139. ALL REPORTING WILL BE COMPLETED ON MFR 2518422-2025-043139. PLEASE DISREGARD MFR 2518422-2026-009612.
Description of Event or Problem · 0
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES IN THE AIR PATH. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5774 | REP DREAMSTATION AUTO CPAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | UDSX500S11F | 00606959429765 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |