MAUDE MDR 25341013
- MDR report key
- 25341013
- Report number
- 2518422-2026-017736
- Event key
- 0
- Event type
- 3
- Date of event
- 2026-05-14
- Date received
- 2026-05-31
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 150229 | DREAMSTATION AUTO CPAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | RESPIRONICS, INC. | BZD | DSX500T11C | DSX500T11C | | | | | N | N |
| 288058 | DREAMSTATION AUTO CPAP | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | RESPIRONICS, INC. | BZD | DSX500T11C | DSX500T11C | | | | | N | N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2026-05-31 | 0 | |
Event Narratives#
No narrative records found.