MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KIWI OMNI VACUUM DELIVERY SYSTEM

Model Number	VAC-6000MT
Health Effect - Clinical Code	Skull Fracture (2077)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have requested additional information but the hospital said that at this time, the incident is under investigation and the requested information cannot be provided at this time.
Event or Problem Description
It was reported that the baby had a skull fracture post use.

• Brand Name: KIWI OMNI VACUUM DELIVERY SYSTEM
• Common Device Name: VACUUM DELIVERY SYSTEM
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• MDR Report Key: 6874427
• Report Number: 1722684-2017-00002
• Device Sequence Number: 1209812
• Product Code: HDB
• UDI-Device Identifier: 00814247020642
• UDI-Public: 00814247020642
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: No Information
• Device Model Number: VAC-6000MT
• Device Lot Number: UKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 07/20/2017
• Initial Report FDA Received Date: 09/18/2017
• 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: Hospitalization
• Patient Age: 1 HR