FDA Adverse Event
Injury
Summary report: N
LTV PATIENT CIRCUIT
MDR report key: 3803267
·
Received May 9, 2014
Report
- Report Number
- 2031702-2014-00122
- Event Type
- Injury
- Date Received
- May 9, 2014
- Report Date
- August 22, 2014
- Manufacturer
- CAREFUSION 203, INC
- Product Code
- CAI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PEEP VALVE ON PATIENT CIRCUIT WAS STUCK OPEN AND WAS NOT GIVING ANY AIR TO PATIENT. THE PATIENT WAS IN DISTRESS AND WAS MANUALLY VENTILATED. THE LOW PRESSURE ALARM SETTINGS WERE TOO LOW AND THE ALARM VOLUME WAS TURNED DOWN. NO ALARM WAS DETECTED BECAUSE OF THE VENTILATOR ALARM SETTINGS. NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281647 | LTV PATIENT CIRCUIT | CIRCUIT, BREATHING | CAI | CAREFUSION 203, INC | 11558X10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |