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

Model Number	VAC-6000MTE
Health Effect - Clinical Code	Cephalohematoma (2599)
Date of Event	01/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Cephalohematomas are collections of blood that accumulate under the periosteum of the skull bones, usually the parietal, and are limited to the confines of a cranial bone because the periosteum is continuous with the pericranium through the suture lines.Reported incidences for cephalohematomas range in vacuum and spontaneous deliveries range from 1 percent to 25 percent with a mean incidence of 6 percent.The wide variation in reported incidence may be partly explained by the fact that cephalohematomas may develop several hours and sometimes days after the birth and also because small hematomas may pass unnoticed or the diagnosis may be incorrect.Cephalohematomas that occur during a vacuum delivery have been associated with poor cup application on the fetal scalp and difficult deliveries.Resolution of cephalohematomas occurs rapidly over a matter of days but large cephalohematomas may take longer, possibly two or three weeks to disappear completely.Complications are rare and no specific therapy is required.
Event or Problem Description
Event description provided by the distributor: "junior reg applied cup - pop off, it was discarded.Dr (b)(6) applied second cup (sample enclosed) baby made progress, slow loss of suction.Baby delivered with cephalohaematoma, went to nicu.Baby and mum are fine.Lot olm recorded 171117".

• 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: 7232966
• Report Number: 1722684-2018-00001
• Device Sequence Number: 1994106
• 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: user facility
• Initial Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 01/31/2018

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: 07/28/2019
• Device Model Number: VAC-6000MTE
• Device Lot Number: 171117
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 01/31/2018
• 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: Hospitalization
• Patient Age: 1 HR