FDA Adverse Event
Malfunction
Summary report: N
PNEUMO SURE HIGH FLOW INSUFFLATOR
MDR report key: 1876609
·
Received October 13, 2010
Report
- Report Number
- 2936485-2010-00764
- Event Type
- Malfunction
- Date Received
- October 13, 2010
- Date of Event
- September 27, 2010
- Report Date
- September 27, 2010
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- FCX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PROCEDURE, THE UNIT SHUT OFF RESULTING IN A TEN MINUTE DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PNEUMO SURE HIGH FLOW INSUFFLATOR | INSUFFLATOR | FCX | STRYKER ENDOSCOPY SAN JOSE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |