FDA Adverse Event
Injury
Summary report: N
LTV
MDR report key: 2421063
·
Received January 13, 2012
Report
- Report Number
- 2031702-2012-00019
- Event Type
- Injury
- Date Received
- January 13, 2012
- Date of Event
- December 14, 2011
- Manufacturer
- CAREFUSION 203, INC
- Product Code
- CBK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Additional Manufacturer Narrative · 1
NA.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR STARTED SPARKING AT THE PIGTAIL AND THEN SHUT DOWN AND RESTARTED WITH AN AUDIBLE ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND MANUALLY VENTILATED UNTIL PLACED ON A BACK-UP VENTILATOR. NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LTV | VENTILATOR, CONTINUOUS/CBK | CBK | CAREFUSION 203, INC | LTV 950 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 YR | Required Intervention | NI/NI |