FDA Adverse Event
Malfunction
Summary report: N
UNIVERSAL F FLEX CIRCUIT
MDR report key: 4877730
·
Received June 29, 2015
Report
- Report Number
- 1824226-2015-00003
- Event Type
- Malfunction
- Date Received
- June 29, 2015
- Date of Event
- May 7, 2015
- Report Date
- June 25, 2015
- Manufacturer
- KING SYSTEMS CORP.
- Product Code
- CAI
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT APPEARS THAT THE BREATHING CIRCUIT WAS NOT TESTED PRIOR TO USE PER THE INSTRUCTIONS FOR USE.
Description of Event or Problem · 1
WHEN STARTING ANESTHESIA INDUCTION, IT WAS OBSERVED THAT NO OXYGEN WAS BEING DELIVERED TO THE PT. IT APPEARED THAT THE BREATHING CIRCUIT WAS COLLAPSED. THERE WAS NO INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 420172 | UNIVERSAL F FLEX CIRCUIT | BREATHING CIRCUIT | CAI | KING SYSTEMS CORP. | FF370-61Z | 1670807 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |