FDA Adverse Event
Malfunction
Summary report: N
SIDNE SMART 40L CORE INSUFFLATOR
MDR report key: 2003796
·
Received February 7, 2011
Report
- Report Number
- 2936485-2011-00077
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 14, 2011
- Report Date
- January 14, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- HIF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT WAS RETURNED FOR INVESTIGATION. THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE PRODUCT WAS EVALUATED OVER A 2-DAY PERIOD USING A TEST FIXTURE. THE ALARM SYSTEM FUNCTIONED AS SPECIFIED. THE SYSTEM VENTED ACCORDING TO SPECIFICATION. WHEN AIR WAS RELIEVED FROM THE SYSTEM, THE PRODUCT PUMPED MORE AIR BACK INTO THE TEST FIXTURE, AS SPECIFIED. OVERALL, THE PRODUCT FUNCTIONED AS SPECIFIED. IN SUM, THE REPORTED FAILURE COULD NOT BE CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT KEPT TURNING OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIDNE SMART 40L CORE INSUFFLATOR | INSUFFLATOR | HIF | STRYKER ENDOSCOPY SAN JOSE | 0703CE662 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |