MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KIWI® OMNICUP®; EXTRACTOR, VACUUM, FETAL

Model Number	VAC-6000MT
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When applying the vacuum, and suction was attempted, the device "fell apart".

• Brand Name: KIWI® OMNICUP®
• Common Device Name: EXTRACTOR, VACUUM, FETAL
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 20757030
• Report Number: 20757030
• Device Sequence Number: 8561067
• Product Code: HDB
• UDI-Device Identifier: 00814247020642
• UDI-Public: (01)00814247020642
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2024
• Report Date (Section F): 11/18/2024

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
• Device Model Number: VAC-6000MT
• Device Catalogue Number: VAC-6000MT
• Device Lot Number: 241065
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 11/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Date Report Sent to FDA: 11/18/2024