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

Model Number	VAC-6000MTE
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Hypoxia (1918)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Loss of vacuum can occur for a multitude of reasons.The majority of reasons are clinically related, some of which are controllable (ie., cup placement, traction force and direction, vacuum level, etc) while others are not controllable (ie., amount of fetal scalp hair and edema, size of fetus, maternal effort, etc).It appears that the vacuum was dislodged once (popped-off) during this delivery which was carried out because the fetus was not tolerating the procedure (suspected hypoxia).Pop-offs are a known potential effect of any vacuum delivery.It is clinical innovation's recommendation to consider an alternative method of delivery if the cup comes off twice.
Event or Problem Description
Term +5 days.Spontaneous assist of labour programed well during 1st stage of labour at 15:15 fully dilated.Kiwi delivery required for abnormal cte - subacute hypoxia.On 2nd traction - cup detached off fetal head.2nd kiwi used - head delivered following 3rd pull.

• 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
• MDR Report Key: 9696600
• Report Number: 1722684-2020-00004
• Device Sequence Number: 19423638
• Product Code: HDB
• UDI-Device Identifier: 00814247020659
• UDI-Public: 00814247020659
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2021
• Device Model Number: VAC-6000MTE
• Device Lot Number: 190060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 02/11/2020
• 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: Other