MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KIWI® OMNICUP®; EXTRACTOR, VACUUM, FETAL

Model Number	VAC-6000M
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The kiwi vacuum was opened and intended to be used during a cesarean delivery.The physicians were having difficulty extracting the infant so to assist in delivery, it was reported that the vacuum suction did not achieve suction.

• Brand Name: KIWI® OMNICUP®
• Common Device Name: EXTRACTOR, VACUUM, FETAL
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 8132450
• Report Number: 8132450
• Device Sequence Number: 16177560
• Product Code: HDB
• UDI-Device Identifier: 00814247020000
• UDI-Public: (01)00814247020000
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/30/2018
• Report Date (Section F): 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VAC-6000M
• Device Catalogue Number: VAC-6000M
• Device Lot Number: 181034
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 95
• Date Report Sent to FDA: 11/30/2018