MAUDE Adverse Event Report: CLINICAL INNOVATIONS DEVICE: KIWI OMNICUP; KIWI VACUUM DELIVERY SYSTEM, OMNICUP® WITH TRACTION FORCE INDICATOR

Model Number	VAC-6000MTE
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is being reported since information suggests that during use with this device, it did not maintain vacuum.It is unknown whether the c-section was the result of another factor.Information reported indicated the patient was traumatized, but no further detail provided.Sample analysis:no sample has been returned conclusion; unable to confirm the complaint since no sample was returned.Device history lot review: there is nothing relative to this lot.If any additional information becomes available, a supplemental will be reported.This complaint is now closed.
Event or Problem Description
Kiwi applied correctly then deflated at first attempt to pull.Not a pop-off.There was caput this time so vacuum had to be achieved.It was reported the patient was traumatized but no further detail provided.The patient underwent a c-section under general anesthesia.No sample available.

• Brand Name: DEVICE: KIWI OMNICUP
• Common Device Name: KIWI VACUUM DELIVERY SYSTEM, OMNICUP® WITH TRACTION FORCE INDICATOR
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• MDR Report Key: 8633595
• Report Number: 1722684-2019-00010
• Device Sequence Number: 11182730
• Product Code: HDB
• UDI-Device Identifier: 00814247020642
• UDI-Public: 00814247020642
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: VAC-6000MTE
• Device Lot Number: 180824
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other