FDA Adverse Event
Injury
Summary report: N
2182466-2007-00001
MDR report key: 829509
·
Received March 20, 2007
Report
- Report Number
- 2182466-2007-00001
- Event Type
- Injury
- Date Received
- March 20, 2007
- Product Code
- BZO
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE PT BREATHING CIRCUIT INVOLVED IN THE INCIDENT WAS DISCARDED BY THE USER FACILITY SO IT IS NOT AVAILABLE FOR EVAL. THE USER FACILITY DID REPORT TO US THAT THEY HAVE THREE REMAINING CIRCUITS FROM THE BAG THAT THEY DID VISUALLY INSPECT AND FOUND TO BE INTACT. THE LOT NUMBER OF THE CIRCUIT IS UNK AT THIS TIME. A REVIEW OF OUR COMPLAINTS HISTORY WAS DONE AND THERE HAVE BEEN NO OTHER INCIDENTS OF CRACKED/KINKED PT HOSES REPORTED. THE VENTILATOR THAT WAS IN USE AT THE TIME OF THE INCIDENT WAS A PNEUPAC PARAPAC P20DNUS, MANUFACTURED IN 4/1998. THIS MODEL IS PNEUMATIC ONLY AND DOES NOT HAVE ANY ELECTRONIC ALARMS. IT DOES HAVE A HIGH PRESSURE PNEUMATIC ALARM, BUT THERE IS NO AUDIBLE ALARM FOR LOW PRESSURE CONDITIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BZO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |