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

Model Number	VAC-6000ME
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if an injury occurred.A 15 minute delay may result in an injury to the infant.It is highly unlikely we are getting the sample.A supplemental will be filed for any additional update or information.
Event or Problem Description
They did not manage to achieve vacuum with the unit.No consequences for patient or baby but a delay of 15 min was reported.No further information was reported.No sample.
Additional Manufacturer Narrative
We have received the device and have completed our investigation.The device history record review has been performed on lot 181003.No ncr or deviation was found.The device met all the specifications outlined for release of the product.Sample analysis: a visual inspection was performed on the returned device related to vacuum generation.No signs of damage or breakage was found on the device.The device underwent functionality testing.The functionality test was passed.The device generated and maintained vacuum with no issues with the device.Conclusion: the reported complaint is not confirmed.This complaint will now be closed.We have information that no harm had occurred to either the mother or baby.

• Brand Name: KIWI OMNICUP
• Common Device Name: KIWI VACUUM DELIVERY SYSTEM, OMNICUP
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• MDR Report Key: 8661093
• Report Number: 1722684-2019-00011
• Device Sequence Number: 2299181
• Product Code: HDB
• UDI-Device Identifier: 00814247020000
• UDI-Public: 00814247020000
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/07/2020
• Device Model Number: VAC-6000ME
• Device Lot Number: 181003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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