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

Model Number	VAC-6000MTE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received from the reporter, a supplemental report may be submitted.Complaints will continued to be monitored for trends.
Event or Problem Description
Incident description: occurrence of the incident: the vacuum cup used did not function properly: "the cable stretched abnormally without breaking, instead of providing the resistance to allow traction." immediate action: - replacement of the device with a new one: "attempted vacuum cup placement due to fetal bradycardia, preventing the fetal mobile from progressing." code red caesarean section for bradycardia and instrument failure.Immediate apparent consequences: for patients: for the mother, prolonged delivery time with significant pain and a code red caesarean section.For the baby: bradycardia and potential risk of fetal distress.For professionals: event management - stress - work overload.

• 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: 23370346
• Report Number: 1722684-2025-00013
• Device Sequence Number: 8915810
• Product Code: HDB
• UDI-Device Identifier: 00814247020659
• UDI-Public: 00814247020659
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VAC-6000MTE
• Device Lot Number: 250483
• 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: 10/01/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown