FDA Adverse Event
Death
Summary report: N
LTV
MDR report key: 4157481
·
Received October 9, 2014
Report
- Report Number
- 2031702-2014-00221
- Event Type
- Death
- Date Received
- October 9, 2014
- Date of Event
- September 7, 2014
- Report Date
- August 17, 2015
- Manufacturer
- CAREFUSION 203, INC
- Product Code
- CBK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- RESPIRATORY THERAPIST
- Health Professional
- N
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE VENTILATOR HAD AN AUDIBLE DISC/SENSE ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR, MANUALLY VENTILATED, AND TAKEN TO THE HOSPITAL. THE PATIENT HAD A HEART ATTACK WHILE CONNECTED TO THE VENTILATOR AND WAS PRONOUNCED DEAD AT THE HOSPITAL. THE RESPIRATORY THERAPIST (RT) HAD CHECKED THREE PATIENT CIRCUITS AND THEY HAD FAILED THE LEAK TEST. THE RT CONNECTED A KNOWN GOOD PATIENT CIRCUIT AND THE VENTILATOR PASSED THE LEAK TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 635227 | LTV | VENTILATOR, CONTINUOUS | CBK | CAREFUSION 203, INC | LTV 950 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |