FDA Adverse Event
Death
Summary report: N
ESPIRIT
MDR report key: 3960714
·
Received July 23, 2014
Report
- Report Number
- MW5037413
- Event Type
- Death
- Date Received
- July 23, 2014
- Date of Event
- July 20, 2014
- Report Date
- July 22, 2014
- Manufacturer
- PHILIPS RESPIRONICS
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
VENTILATOR REGISTERED AS VENT INOP AND SHUT DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 429833 | ESPIRIT | VENTILATOR | CBK | PHILIPS RESPIRONICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death | RESPIRONICS REF 1038401| AMERIVAC BREATHING BACTERIA FILTER LOT 050914MB| KIMBERLY-CLARK KIM VENT CLOSED SUCTION SYSTEM| REF 001793| COVIDIEN TRACH SHILEY 6DCT LOT 13F0648JZX| CAREFUSION AIRLIFE VOLUME VENTILATOR CIRCUIT| REF 221038 |