FDA Adverse Event
Malfunction
Summary report: N
KIWI OMNI
MDR report key: 1519762
·
Received October 12, 2009
Report
- Report Number
- 1519762
- Event Type
- Malfunction
- Date Received
- October 12, 2009
- Date of Event
- August 24, 2009
- Report Date
- October 12, 2009
- Manufacturer
- CLINICAL INNOVATIONS, INC.
- Product Code
- HDB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
Narratives
Description of Event or Problem · 1
VACUUM APPLIED BY DR. FOR FETAL DECELERATIONS, STATION AT +2, PRESSURE APPLIED; BARELY PULLED AND WIRE SNAPPED OFF OF HANDLE. NO INJURY TO BABY OR PATIENT NOTED. RE-APPLIED A SECOND VACUUM. NO COMPLICATIONS. DELIVERY OF BABY WITH ONE PULL OF KIWI.
Description of Event or Problem · 1
VACUUM APPLIED BY DR. FOR FETAL DECELERATIONS, STATION AT +2, PRESSURE APPLIED; BARELY PULLED AND WIRE SNAPPED OFF OF HANDLE. NO INJURY TO BABY OR PATIENT NOTED. RE-APPLIED A SECOND VACUUM. NO COMPLICATIONS. DELIVERY OF BABY WITH ONE PULL OF KIWI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KIWI OMNI | VACUUM DELIVERY SYSTEM | HDB | CLINICAL INNOVATIONS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 29 YR |