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

Model Number	VAC-6000M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint is not confirmed.No product evaluation could be performed because the device was not returned and no photos were provided.A dhr review was performed and no deviations or ncrs were found to be initiated for lot# 221542.Risk assessment per fmea risk-0029 rev.02, the complaint may be associated with the following potential failure mode: potential failure mode: user creates vacuum but fails to exclude any maternal tissue potential effects: failure to exclude any maternal tissue causes air/vacuum leak harm 1: delayed procedure severity: 1 potential cause: lack of attention, not qualified personnel probability of occurrence: 1 risk is considered "acceptable" harm 2: delayed procedure with fetal distress severity: 4 potential cause: lack of attention, not qualified personnel probability of occurrence: 1 risk is considered "monitor" no root cause can be determined because the complaint is not confirmed.
Event or Problem Description
In the customer words: "the physician was attempting to carry out a vacuum delivery of a baby.The kiwi omni cup, failed to maintain pressure.Physician used three ( two of one lot and one of another), all giving same malfunction.Once the device was pumped up to a pressure, the pressure gauge released and there was a loss of pressure, causing the traction to be ineffective in helping baby's birth.Device has been replaced with new lot numbered devices.Mom was stable but baby apgar 2 and baby needed resus.".

• Brand Name: KIWI VACUUM ASSISTED DELIVERY SYSTEM
• Common Device Name: VACUUM DELIVERY DEVICE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: zulmar molina ; 747 w 4170 s; murray, UT 84123
• MDR Report Key: 16854921
• Report Number: 1722684-2023-00006
• Device Sequence Number: 7648294
• Product Code: HDB
• UDI-Device Identifier: 00814247020000
• UDI-Public: 00814247020000
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2024
• Device Model Number: VAC-6000M
• Device Lot Number: 221095
• 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: 04/03/2023
• Initial Report FDA Received Date: 05/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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: Required Intervention
• Patient Sex: Unknown