FDA Adverse Event
Injury
Summary report: N
DREAMSTATION AUTO CPAP
MDR report key: 19975480
·
Received August 13, 2024
Report
- Report Number
- 2518422-2024-51025
- Event Type
- Injury
- Date Received
- August 13, 2024
- Date of Event
- October 9, 2023
- Report Date
- August 13, 2024
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- UDI-DI
- 00606959025646
- PMA / PMN Number
- K131982
- Removal / Correction Number
- Z-1974-2021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
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 IDIOPATHIC PULMONARY FIBROSIS (IPF), CHRONIC PNEUMONIA AND BRONCHITIS. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. 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 |
|---|---|---|---|---|---|---|---|
| 1683605 | DREAMSTATION AUTO CPAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | DSX500T11C | 00606959025646 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |