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

Model Number	VAC-6000MTE
Health Effect - Clinical Codes	Death (1802); Suffocation (2088)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, clinical innovations has little information on this unfortunate incident and we are trying to gather more information on how the kiwi product could have contributed to the suffocation of the infant.We will follow up with device investigation and any other details we get from the hospital where it happened.
Event or Problem Description
Infant passed during delivery due to suffocation.Two kiwi vacuum delivery systems were used during the delivery.
Event or Problem Description
Infant passed during delivery due to suffocation.Two kiwi vacuum delivery systems were used during the delivery.
Additional Manufacturer Narrative
Clinical innovations received a follow up report from the distributor that the infant did not pass away.The infant was resucitated andi intubated.

• 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: 7589560
• Report Number: 1722684-2018-00007
• Device Sequence Number: 1698823
• Product Code: HDB
• UDI-Device Identifier: 00814247020659
• UDI-Public: 00814247020659
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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: 12/15/2019
• Device Model Number: VAC-6000MTE
• Device Lot Number: 171833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 09/24/2018
• 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: Death; Hospitalization
• Patient Age: 1 DA