MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-04-30 for KIWI COMPLETE VACUUM DELIVERY SYSTEM VAC-6000MTE manufactured by Clinical Innovations, Llc.
[143672152]
Clinical innovations is investigating the incident and requesting additional information on patient outcome. If any additional information is obtained, a follow-up report will be submitted. It has come to our attention that the wrong year was used in the submission number.
Patient Sequence No: 1, Text Type: N, H10
[143672153]
Applied kiwi at the right flexion point for (b)(6) baby with oa presentation. Cup pressure was normal at the beginning as shown on monitor and suddenly pressure was dropped + cup dislodged with traction. Not a pop-off, (b)(6) spontaneous onset of labor, bmi 24. 34 experienced user. Used forceps baby went to hdu for observation for hematoma.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722684-2019-00003 |
| MDR Report Key | 8567034 |
| Report Source | FOREIGN |
| Date Received | 2019-04-30 |
| Date of Report | 2019-04-09 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-04-09 |
| Device Manufacturer Date | 2018-07-27 |
| Date Added to Maude | 2019-04-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ANDREA GADSBY |
| 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 | 0 |
| Brand Name | KIWI COMPLETE VACUUM DELIVERY SYSTEM |
| Generic Name | VACUUM DELIVERY SYSTEM |
| Product Code | HDB |
| Date Received | 2019-04-30 |
| Returned To Mfg | 2019-03-28 |
| Model Number | VAC-6000MTE |
| Lot Number | 181130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-30 |