FDA Adverse Event
Death
Summary report: N
LTV
MDR report key: 2603358
·
Received May 30, 2012
Report
- Report Number
- 2031702-2012-00137
- Event Type
- Death
- Date Received
- May 30, 2012
- Date of Event
- May 1, 2012
- Report Date
- May 29, 2012
- Manufacturer
- CAREFUSION 203, INC
- Product Code
- CBK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT ON (B)(6) 2012, THE PT WAS LEFT ALONE FOR APPROXIMATELY 1 1/2 HOURS. WHEN THE PT'S MOTHER RETURNED, SHE FOUND THE VENTILATOR WAS "NOT WORKING PROPERLY AND WAS ALARMING WITH A FLASHING DISPLAY". THE PT HAD PASSED AWAY.
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 | 37 YR | Death |