MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-06 for KIWI VACUUM DELIVERY SYSTEM VAC-6000M manufactured by Clinical Innovations, Llc.
[187260191]
Clinical innovations is currently working on gathering additional information on this incident and patient outcome. A follow-up report will be sent if any new information is received.
Patient Sequence No: 1, Text Type: N, H10
[187260192]
Doctor applied kiwi vacuum cephalically to fetus in distress, kiwi vacuum suction increased to appropriate level and kiwi vacuum literally "fell" off fetal head. This was not a pop-off since no traction was applied. A second kiwi vacuum was opened and applied with the same outcome. Infant was ultimately delivered by forceps. This infant required advanced resuscitation measures and eventually was transferred to a tertiary care center for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2020-00002 |
| MDR Report Key | 9555978 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-08 |
| Date Mfgr Received | 2019-12-17 |
| Device Manufacturer Date | 2019-07-23 |
| Date Added to Maude | 2020-01-06 |
| 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. KELLIE STEFANIAK |
| Manufacturer Street | 747 W 4170 S |
| Manufacturer City | MURRAY UT 84123 |
| Manufacturer Country | US |
| Manufacturer Postal | 84123 |
| Manufacturer Phone | 8012688200 |
| 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 VACUUM DELIVERY SYSTEM |
| Generic Name | FETAL VACUUM EXTRACTOR |
| Product Code | HDB |
| Date Received | 2020-01-06 |
| Model Number | VAC-6000M |
| Lot Number | 190836 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-06 |