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

Model Number	VAC-6000M
Health Effect - Clinical Codes	Skull Fracture (2077); Cephalohematoma (2599)
Date of Event	03/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cephalohematomas are a known risk factor for vacuums deliveries.As the device was discarded we are unable to evaluate the product and determine how the use of the product could have contributed to the injury.It was reported that the infant appears to not have any long-term deficiencies or sequelae.Clinical innovations will continue to monitor the event and provide any additional data if it becomes available.
Event or Problem Description
A pregnant woman facing the problem of threatened premature delivery started labor at a gestational age of 36 weeks.To cope with the nrfs (non reassuring fetal status), her baby was subject to suction-delivery with the kiwi omni cup.While the cup was applied to the right side from the bending point due to an anomaly of rotation, suctioning was successful without any slippage at the 1st attempt, the baby weighing (b)(6) g, however, was found to have cephalhematoma.Since it grew bigger in a few days, the baby got a ct and was found to suffer a fractured skull in 3 places.

• Brand Name: KIWI VACUUM DELIVERY SYSTEM
• Common Device Name: FETAL VACUUM EXTRACTOR
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray, ut
• MDR Report Key: 10169156
• Report Number: 1722684-2020-00006
• Device Sequence Number: 3361052
• Product Code: HDB
• UDI-Device Identifier: 00814247020000
• UDI-Public: 00814247020000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2020

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: 08/26/2021
• Device Model Number: VAC-6000M
• Device Lot Number: 191028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2020
• Initial Report FDA Received Date: 06/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other