FDA Adverse Event
Malfunction
Summary report: N
SIDNE SMART READY 40-LITER HIGH FLOW INSUFFLATOR
MDR report key: 2050059
·
Received April 4, 2011
Report
- Report Number
- 2936485-2011-00199
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 11, 2011
- Report Date
- March 11, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- FCX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT NO PRESSURE WOULD BUILD UP. FURTHER THE UNIT WAS SHOWING THAT FLUID WAS GOING OUT WHEN NO FLUID WAS GOING OUT. FURTHER THE UNIT WASN'T INSUFFLATING ENOUGH PRESSURE IN THE CAVITY TO REACH THE PRESSURE SET POINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIDNE SMART READY 40-LITER HIGH FLOW INSUFFLATOR | INSUFFLATOR | FCX | STRYKER ENDOSCOPY SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |