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

Model Number	VAC-6000ME
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoxia in Utero (2210)
Date of Event	06/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On november 29, 2018, clinical innovations was informed by the user facility that a serious injury had occurred that was not previously communicated when the complaint was first received.The physician involved in the delivery stated that the baby suffered "severe hypoxic-ischemic encephalopathy" due to the device not working properly.The physician used 4 different devices.No devices will be returned, so we cannot further investigate the root-cause of this event.There are no additional complaints associated with lot 180412 to date.We have reached out to obtain additional information on several occasions and have been told this is all the information available.
Event or Problem Description
We are experiencing difficulties with our vacuum deliveries in the past few days.It seems that kiwi omnicup is not providing enough vacuum to apply sufficient pressure in order to facilitate a successful delivery (with repeated pop-off issue).

• Brand Name: KIWI COMPLETE 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: 8143739
• Report Number: 1722684-2018-00016
• Device Sequence Number: 11000469
• Product Code: HDB
• UDI-Device Identifier: 00814247020635
• UDI-Public: 00814247020635
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/06/2018

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: 03/16/2020
• Device Model Number: VAC-6000ME
• Device Lot Number: 180412
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 12/07/2018
• 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