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

Model Number	VAC-6000M
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	Fetal Distress (1856)
Date of Event	12/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical innovations is currently working on gathering additional information on this incident and patient outcome.A follow-up report will be sent if any new information is received.
Event or Problem Description
Doctor applied kiwi vacuum cephalically to fetus in distress, kiwi vacuum suction increased to appropriate level and kiwi vacuum literally "fell" off fetal head.This was not a pop-off since no traction was applied.A second kiwi vacuum was opened and applied with the same outcome.Infant was ultimately delivered by forceps.This infant required advanced resuscitation measures and eventually was transferred to a tertiary care center for treatment.

• Brand Name: KIWI 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: 9555978
• Report Number: 1722684-2020-00002
• Device Sequence Number: 2082076
• Product Code: HDB
• UDI-Device Identifier: 00814247020000
• UDI-Public: 00814247020000
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/06/2020

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: 07/23/2021
• Device Model Number: VAC-6000M
• Device Lot Number: 190836
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other