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

Model Number	VAC-6000MTE
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hemorrhage, Subgaleal (2603)
Date of Event	04/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subgaleal hemorrhages are very rare complications (reported as low as 4 per 10,000 to 8 per 1,000 deliveries) associated with vacuum-assisted vaginal deliveries.Risk factors for this type of hemorrhage include: nulliparity, malposition, misplacement of the cup, prolonged traction efforts, and pop-offs/detachments of the vacuum cup.Device was discarded.
Event or Problem Description
It was reported by a clinical specialist that they "have had 3 incidents in the last 6 months of babies who have either been delivered by ventouse (omnicup) who have had a bleed between the skull and skin which is known as a subgaleal bleed.".

• Brand Name: KIWI OMNICUP 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: 7106728
• Report Number: 1722684-2017-00001
• Device Sequence Number: 1461273
• 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: foreign,user facility
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2017

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: 11/11/2018
• Device Model Number: VAC-6000MTE
• Device Lot Number: 161615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 12/11/2017
• 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