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	Fetal Distress (1856); Pain (1994); Distress (2329)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Description of the incident: during an instrumental delivery for bradycardia in the baby, despite easy placement of the device and adhesion of the suction cup to the baby's head, during the maneuver performed by the obstetrician, the handle of the device became completely detached from the rest of the device, with the springs exteriorizing and one suction cup still in place.Current state of the patient: for the mother: prolongation of the extraction duration with increased pain, stress with post-traumatic anxiety, and other potential risks.For the baby: fetal distress in a newborn already experiencing bradycardia due to the prolonged extraction time, increased pain due to multiple vacuum repositionings requiring unusual medical intervention, probable post-traumatic stress.For the obstetric surgeon: risk of falling during the delivery procedure with a risk of the newborn falling.
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.

• 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 ; FR 84123
• MDR Report Key: 23465508
• Report Number: 1722684-2025-00014
• Device Sequence Number: 15673374
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2025

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: 250141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/04/2025
• 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