FDA Adverse Event
Malfunction
Summary report: N
RESPIRONICS
MDR report key: 4080816
·
Received September 5, 2014
Report
- Report Number
- MW5038121
- Event Type
- Malfunction
- Date Received
- September 5, 2014
- Date of Event
- August 28, 2014
- Report Date
- September 5, 2014
- Manufacturer
- PHILLIPSA
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
VENTILATOR SHUT DOWN. NO WARNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 543362 | RESPIRONICS | ESPRIT VENTILATOR | CBK | PHILLIPSA | 989805611721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |