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

Model Number	VAC-6000ME
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the device is analyzed, a follow-up report will be sent with the findings.
Event or Problem Description
Kiwi breaks up during delivery the cup part was caught on the child's head (the child was not born yet) and the hose+ handle was left in the hand of the leader in the middle of the operation.The removal of the cup was painful and painful birth for the baby while the vacuum was in the cup while the hose and the handle were removed.The operation was not difficult (it did not have to be exceptionally hard).With a new cup, the child was born without problems.
Additional Manufacturer Narrative
We have completed our investigation into the stated complaint and can confirm that for the returned device the cable was detached from the cup.A portion of the plastic that the cable connects to in the cup was visible in the loop of the cable indicating that excessive force may have been applied during pull.When the device breaks in such fashion; it will lose vacuum and the cup will detach from the head.Attachment: (b)(4).
Event or Problem Description
Kiwi breaks up during of delivery.The cup part was caught on the child's head (the child was not born yet) and the hose + handle was left in the hand of the leader in the middle of the operation.The removal of the cup was a painful and painful birth for the baby while the vacuum was in the cup while the hose and the handle were removed.The operation was not difficult (it did not have to be exceptionally hard).With a new cup, the child was born without problems.

• Brand Name: KIWI OMNI VACUUM DELIVERY SYSTEM
• Common Device Name: FETAL VACUUM EXTRACTOR
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 7106744
• Report Number: 1722684-2017-00005
• Device Sequence Number: 1156716
• Product Code: HDB
• UDI-Device Identifier: 00814247020635
• UDI-Public: 00814247020635
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2018

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: 10/18/2018
• Device Model Number: VAC-6000ME
• Device Lot Number: 161479
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 11/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 1 DA