FDA Adverse Event
Other
Summary report: N
ESPRIT
MDR report key: 615241
·
Received July 29, 2004
Report
- Report Number
- 2031642-2004-00136
- Event Type
- Other
- Date Received
- July 29, 2004
- Date of Event
- June 30, 2004
- Report Date
- June 30, 2004
- Manufacturer
- RESPIRONICS CALIFORNIA, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE UNIT SHUT DOWN WHEN THE VENTILATOR'S BACKUP BATTERY DEPLETED DURING TRANSPORT OF A PT. THE CUSTOMER REPORTED THE VENTILATOR DID ALARM AT SHUT DOWN, AND THERE WAS NO PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ESPRIT | VENTILATOR | CBK | RESPIRONICS CALIFORNIA, INC. | V1000 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |