MAUDE Adverse Event Report: KENTEC MEDICAL INC KIWI PROCUP VACUUM DELIVERY SYSTEM; VACUUM CUP

Model Number VAC-6000S

Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2016

Event Type  malfunction  

Event Description

Kiwi procup vacuum delivery system malfunctioned (fell apart) during an emergent cesarean delivery case.When the vacuum was placed on the baby's head and the handle was depressed, the unit malfunctioned and fell apart.Multiple similar situations have occurred with this device.

• Brand Name: KIWI PROCUP VACUUM DELIVERY SYSTEM
• Type of Device: VACUUM CUP
• Manufacturer (Section D): KENTEC MEDICAL INC
• MDR Report Key: 5646267
• MDR Text Key: 44999457
• Report Number: MW5062188
• Device Sequence Number: 1
• Product Code: HDB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VAC-6000S
• Device Catalogue Number: SKU# KMEVAC6000SH
• Device Lot Number: UNSURE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1