MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KIWI COMPLETE VACUUM DELIVERY SYSTEM; FETAL VACUUM EXTRACTOR

Model Number	VAC-6000ME
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	06/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Description of incident: malfunction during the removal of the kiwi suction cup from the newborn's occiput.The removal button on the handle was stuck.It was impossible to unblock it and create the necessary suction to remove the cup.It was necessary to disassemble it, removing the spring from the handle.This caused a delay in removal, resulting in a significant cephalic bump that could have caused a subcutaneous hematoma.The baby's occiput was purplish (significant occipital hump + small hematoma).Current patient condition: significant occipital hump that may have caused a subcutaneous hematoma.The baby's occiput was purplish (significant occipital hump + small hematoma).
Additional Manufacturer Narrative
If any additional information is received from the reporter, a supplemental report may be submitted.Complaints will continue to be monitored for trends.

• Brand Name: KIWI COMPLETE VACUUM DELIVERY SYSTEM
• Common Device Name: FETAL VACUUM EXTRACTOR
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4150 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4150 s; murray UT 84123
• Manufacturer Contact: thomas hirte ; 747 w 4150 s; murray, UT 84123
• MDR Report Key: 23511045
• Report Number: 1722684-2025-00016
• Device Sequence Number: 13194835
• Product Code: HDB
• UDI-Device Identifier: 00814247020635
• UDI-Public: 00814247020635
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2025
• Device Model Number: VAC-6000ME
• Device Lot Number: 230470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown