FDA Adverse Event
Death
Summary report: N
PULMONETIC
MDR report key: 1657858
·
Received April 9, 2010
Report
- Report Number
- 2031702-2010-00063
- Event Type
- Death
- Date Received
- April 9, 2010
- Date of Event
- February 26, 2010
- Report Date
- April 9, 2010
- Manufacturer
- CAREFUSION 203, INC
- Product Code
- CBK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NURSE DISCOVERED THE PT WAS BLUE WHILE CONNECTED TO THE VENTILATOR. CPR WAS INITIATED, BUT THE PT PASSED AWAY. THE VENTILATOR HAD AN AUDIBLE ALARM WHEN THE REPORTED PROBLEM OCCURRED. TESTING BY A TECHNICIAN FOUND THE VENTILATOR FUNCTIONED NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULMONETIC | VOLUME VENTILATOR | CBK | CAREFUSION 203, INC | LTV 1150 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 9 MO | Death |