MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KIWI VACUUM DELIVERY SYSTEM; FOETEL VACUUM ASSISTED DELIVERY DEVICE

Model Number	VAC-6000MTE
Medical Device Problem Codes	Material Separation (1562); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fetal Distress (1856); Distress (2329)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Corrective action has been opened to investigate the failure mode.Additionally, field actions are underway.Customer has been contacted for additional information regarding patient outcome.If any additional information becomes available, a follow-up report may be submitted.
Event or Problem Description
Complaint description from user is as follows: "13 apr 2026: updated information: "one of these batches": 251652, 250956, 251597."outside paperwork was discarded and not able to be retrieved." incident description: baby was delivered at 41+3 weeks following an uncomplicated antenatal course.The baby was born in poor condition after fetal bradycardia and a prolonged instrumental delivery due to a snapped kiwi, meeting criteria a and b for therapeutic hypothermia.She was intubated and ventilated shortly after birth, transferred to heartlands hospital, birmingham for cooling on day of birth, and repatriated to kmh on (b)(6) 2026.Therapeutic hypothermia was completed, and she was rewarmed on 20/03.She required mechanical ventilation until 20/03, when she was successfully extubated.Since then, she has been self-ventilating in air.She was initially screened for sepsis; infection markers were normal and blood cultures were sterile, so antibiotics were discontinued.She has remained clinically stable with normal neurological examinations.Mri performed showed restricted diffusion of the internal capsule consistent with moderate to severe hie.It is likely that she may develop cerebral palsy in time but it is difficult to know to what extent this will affect her.She will have ongoing physiotherapy as an outpatient to monitor tone closely and ensure early recognition of concerns.Patient condition: patient was discharged.Device event description: initial kiwi snapped on 1st pull.2nd kiwi applied which popped off head.Patient was transferred to theatre to continue delivery which caused a delay in delivery.Indication for product: instrumental delivery required due to fetal bradycardia.Describe event or problem in detail: instrument applied to fetal head to aid delivery.1st instrument broke during use and was removed.A second cup was applied which popped off during use.The patient was transferred to theatre for another method of assisted delivery.The patient delivered without assistance on arrival in theatre.Other relevant history, including preexisting medical conditions: nil relevant uncomplicated antenatal.".

• Brand Name: KIWI VACUUM DELIVERY SYSTEM
• Common Device Name: FOETEL VACUUM ASSISTED DELIVERY DEVICE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 west 4170 south; murray UT 84123
• Manufacturer Contact: thomas hirte ; 747 west 4170 south; murray, UT 84123 ; 9782776432
• MDR Report Key: 24954557
• Report Number: 1722684-2026-00010
• Device Sequence Number: 5278153
• Product Code: HDB
• UDI-Device Identifier: 00814247020659
• UDI-Public: 00814247020659
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/22/2026

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown