FDA Adverse Event
Death
Summary report: N
LTV PATIENT CIRCUIT
MDR report key: 2161141
·
Received July 7, 2011
Report
- Report Number
- 2031702-2011-00145
- Event Type
- Death
- Date Received
- July 7, 2011
- Date of Event
- May 28, 2011
- Report Date
- July 6, 2011
- Manufacturer
- CAREFUSION 203, INC.
- Product Code
- CAI
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2011. IT WAS ALSO REPORTED BY THE PATIENT'S DAUGHTER THAT TWO WEEKS PRIOR TO THE PATIENT'S DEATH, THE PRESSURE LINE THAT GOES TO THE PEEP VALVE WOULD STAY ON THE VENTILATOR BUT COME OFF JUST ENOUGH TO MAKE THE PEEP VALVE "MESS UP" AND NOT SET THE ALARMS OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LTV PATIENT CIRCUIT | CIRCUIT, BREATHING / CAI | CAI | CAREFUSION 203, INC. | 10820X10 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Death |