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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KIWI® PROCUP®; EXTRACTOR, VACUUM, FETAL
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CLINICAL INNOVATIONS, LLC KIWI® PROCUP®; EXTRACTOR, VACUUM, FETAL Back to Search Results
Model Number VAC-6000S
Device Problems Difficult to Remove (1528); Increase in Suction (1604); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2017
Event Type  malfunction  
Event Description
The vacuum extractor would not release from the neonate's head.Delivery by vacuum during c-section, the vacuum would not release from infant's head after the infant delivered.
 
Event Description
The vacuum extractor would not release from the neonate's head.Delivery by vacuum during c-section, the vacuum would not release from infant's head after the infant delivered.
 
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Brand Name
KIWI® PROCUP®
Type of Device
EXTRACTOR, VACUUM, FETAL
Manufacturer (Section D)
CLINICAL INNOVATIONS, LLC
747 w 4170 s
murray UT 84123
MDR Report Key6551034
MDR Text Key74603093
Report Number6551034
Device Sequence Number1
Product Code HDB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date10/03/2018
Device Model NumberVAC-6000S
Device Catalogue NumberVAC-6000S
Device Lot Number161403
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/03/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer05/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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