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

Model Number	VAC-6000ME
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint is not confirmed.A product evaluation could not be performed because the device has not been returned and no photos have been provided.Investigation description a dhr review was performed and no deviations or ncrs were found to be initiated for lot# 230003.Risk assessment: per fmea risk-0029 rev.03, the complaint may be associated with the following potential failure mode: potential failure mode: user fails to establish appropriate level (450 - 600 mmhg) of vacuum.Potential effects: the cup will not adhere to the fetal head.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".Root cause analysis.No root cause can be determined because a product evaluation could not be performed and the complaint was not confirmed.
Event or Problem Description
In the customers words "incident : " difficulty in performing the vacuum immediately after application, prolonging the period expulsion and putting the newborn's life at risk".It is unknown if the device is available to be sent back; if the device is returned, a new complaint investigation will be opened.

• Brand Name: KIWI VACUUM ASSISTED DELIVERY SYSTEM
• Common Device Name: VACUUM EXTRACTOR
• 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: 18163762
• Report Number: 1722684-2023-00009
• Device Sequence Number: 15257784
• Product Code: HDB
• UDI-Device Identifier: 00814247020635
• UDI-Public: 00814247020635
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2023

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: 01/18/2025
• Device Model Number: VAC-6000ME
• Device Lot Number: 230003
• 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: 10/20/2023
• Initial Report FDA Received Date: 11/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2023
• 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
• Patient Sex: Unknown