FDA Adverse Event
Malfunction
Summary report: N
DREAMSTATION AUTO CPAP
MDR report key: 19067093
·
Received April 8, 2024
Report
- Report Number
- 2518422-2024-18182
- Event Type
- Malfunction
- Date Received
- April 8, 2024
- Date of Event
- March 21, 2024
- Report Date
- December 3, 2025
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- UDI-DI
- 00606959051522
- PMA / PMN Number
- K131982
- Removal / Correction Number
- Z-1974-2021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
Additional Manufacturer Narrative · 0
IN THIS REPORT, BOX D, E, HAS BEEN UPDATED/CORRECTED.
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 RESPIRATORY TRACT IRRITATION. THERE WAS NO SERIOUS PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105113 | DREAMSTATION AUTO CPAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | DSX500T11C | 00606959051522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |