FDA Adverse Event
Malfunction
Summary report: N
DS2ADV AUTO CPAP
MDR report key: 19056739
·
Received April 6, 2024
Report
- Report Number
- 2518422-2024-16251
- Event Type
- Malfunction
- Date Received
- April 6, 2024
- Date of Event
- March 27, 2024
- Report Date
- June 14, 2024
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- BZD
- PMA / PMN Number
- K200480
- 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
CORRECTED INFORMATION: BOX H: DEVICE MANUFACTURERS (DEVICE) PROBLEM CODE GRID (1): REQUIRED - ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM - NOT APPLICABLE - NOT APPLICABLE - C76126.
Description of Event or Problem · 0
THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW-5152430) IN WHICH THE PATIENT ALLEGES SLEEP DYSFUNCTION. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. 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 |
|---|---|---|---|---|---|---|---|
| 1083250 | DS2ADV AUTO CPAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESPIRONICS, INC. | DSX520H11C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |