MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-03-15 for KIWI OMNI VACUUM DELIVERY SYSTEM VAC-6000ME manufactured by Clinical Innovations, Llc.
[138963725]
Clinical innovations is gathering more information on the patient condition and around the event. If any additional information is obtained, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[138963726]
My patient was already fully effaced, head is on +1 but with severe fetal distress. So i decided to use the kiwi for faster delivery. As i applied the vacuum the head was not working as the wire between the handle and the cap was completely broken. Causing trama to the baby.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2019-00001 |
| MDR Report Key | 8425692 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-03-15 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-02-14 |
| Date Mfgr Received | 2019-04-10 |
| Device Manufacturer Date | 2018-07-20 |
| Date Added to Maude | 2019-03-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS LAURA SMITH |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012667373 |
| Manufacturer G1 | CLINICAL INNOVATIONS, LLC |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIWI OMNI VACUUM DELIVERY SYSTEM |
| Generic Name | VACUUM DELIVERY SYSTEM |
| Product Code | HDB |
| Date Received | 2019-03-15 |
| Model Number | VAC-6000ME |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CLINICAL INNOVATIONS, LLC |
| Manufacturer Address | 747 W 4170 S MURRAY UT 84123 US 84123 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-15 |