KIWI
Report
- Report Number
- 1507817
- Event Type
- Malfunction
- Date Received
- October 6, 2009
- Date of Event
- October 6, 2009
- Report Date
- October 6, 2009
- Manufacturer
- CLINICAL INNOVATIONS, INC.
- Product Code
- HDB
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- VA, US
Narratives
DOCTOR WAS USING THE FLAT KIWI TO HELP DELIVER THE INFANT'S HEAD DURING A C-SECTION WHEN IT BROKE APART. A SECOND KIWI WAS OPENED AND INFANT'S HEAD WAS DELIVERED. AN OBSERVING RESIDENT WROTE - "USED DURING A C-SECTION; USED/PLACED ACCORDING TO MANUFACTURER'S RECOMMENDATIONS. WAS NOT USING VERY MUCH PRESSURE WHEN TUBING DETACHED, EARLY ON - JUST AFTER APPLICATION OF VACUUM."MANUFACTURER RESPONSE (AS PER REPORTER) FOR COMPLETE VACUUM DELIVERY SYSTEM WITH PALM PUMP, KIWI OMNI CUP:THIS INSTANCE JUST HAPPENED TODAY. THIS IS THE FIRST TIME THE DEVICE WAS SAVED. IN THE PAST, THE COMPANY STATED THEY COULD NOT DECIPHER WHAT WENT WRONG.
DOCTOR WAS USING THE FLAT KIWI TO HELP DELIVER THE INFANT'S HEAD DURING A C-SECTION WHEN IT BROKE APART. A SECOND KIWI WAS OPENED AND INFANT'S HEAD WAS DELIVERED. AN OBSERVING RESIDENT WROTE - "USED DURING A C-SECTION; USED/PLACED ACCORDING TO MANUFACTURER'S RECOMMENDATIONS. WAS NOT USING VERY MUCH PRESSURE WHEN TUBING DETACHED, EARLY ON - JUST AFTER APPLICATION OF VACUUM."MANUFACTURER RESPONSE (AS PER REPORTER) FOR COMPLETE VACUUM DELIVERY SYSTEM WITH PALM PUMP, KIWI OMNI CUP:THIS INSTANCE JUST HAPPENED TODAY. THIS IS THE FIRST TIME THE DEVICE WAS SAVED. IN THE PAST, THE COMPANY STATED THEY COULD NOT DECIPHER WHAT WENT WRONG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KIWI | VACUUM ASSISTED DELIVERY SYSTEM | HDB | CLINICAL INNOVATIONS, INC. | KIWI OMNI CUP H833 VAC | 090722 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 DAY |