FDA Adverse Event
Injury
Summary report: N
LTV
MDR report key: 2232598
·
Received August 24, 2011
Report
- Report Number
- 2031702-2011-00177
- Event Type
- Injury
- Date Received
- August 24, 2011
- Date of Event
- July 28, 2011
- Report Date
- August 24, 2011
- Manufacturer
- CAREFUSION 203, INC.
- Product Code
- CBK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN WITH NO AUDIBLE ALARM WHILE CONNECTED TO A PT. THE VENTILATOR SCREEN WENT BLANK AND THE VENTILATOR DID RESTART ON ITS OWN. THE PT TURNED BLUE, PASSED OUT, AND ALLEGEDLY BUMPED HER HEAD DURING THE FALL. THE PT WAS BROUGHT TO A PHYSICIAN. THE PT APPEARS TO BE WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LTV | VENTILATOR, CONTINUOUS | CBK | CAREFUSION 203, INC. | LTV 950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Life Threatening| R |