MAUDE Adverse Event Report: CLINICAL INNOVATIONS LLC. KIWI PRO; EXTRACTOR, VACUUM, FETAL

Model Number	VAC-6000S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Md used kiwi to assist with a cesarean of an iufd.When she attempted to use the palm pump for the vacuum, there was no suction produced.Fda safety report id# (b)(4).

• Brand Name: KIWI PRO
• Common Device Name: EXTRACTOR, VACUUM, FETAL
• Manufacturer (Section D): CLINICAL INNOVATIONS LLC.; murray UT 84123
• MDR Report Key: 14160999
• Report Number: MW5109167
• Device Sequence Number: 17705587
• Product Code: HDB
• UDI-Device Identifier: 00814247020666
• UDI-Public: (01)00814247020666
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2022

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 Expiration Date: 11/02/2023
• Device Model Number: VAC-6000S
• Device Catalogue Number: REF VAC-6000S
• Device Lot Number: 214692
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown