MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC. KIWI OMNICUP TRACTION FORCE; EXTRACTOR, VACUUM, FETAL

Model Number VAC-6000MT

Device Problem Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/13/2023

Event Type  Death  

Event Description

Operative vaginal delivery via kiwi vacuum.Infant with subgaleal bleed.

• Brand Name: KIWI OMNICUP TRACTION FORCE
• Type of Device: EXTRACTOR, VACUUM, FETAL
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC.
• MDR Report Key: 16478724
• MDR Text Key: 310616164
• Report Number: MW5115410
• Device Sequence Number: 1
• Product Code: HDB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VAC-6000MT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male
• Patient Weight: 4 KG
• Patient Ethnicity: Hispanic
• Patient Race: White