MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC KIWI VACUUM ASSISTED DELIVERY SYSTEM; FOETEL VACUUM ASSISTED DELIVERY DEVICE

Model Number	VAC-6000ME
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Follow up is being attempted, no response recieved to date.Investigation description a dhr review was performed and no deviations or ncrs were found to be initiated for lot# 230998.Risk assessment per fmea-00138 [b], the complaint may be associated with the following potential failure mode: potential failure mode 1: user fails to follow recommendations of abandonment; 1) if no descent (progress) of the head occurs after 2 tractions.2) if delivery is not achieved or imminent after 4 tractions, or 3) if the vacuum cup detaches ("pops-off") twice.Potential effects: excessive attempts lead to fetal or maternal injury.Potential failure mode 2: user fails to establish appropriate level (450 - 600 mmhg) of vacuum.Potential effects: the device disengages/pops off the fetal head.Potential failure mode 3: user creates vacuum but fails to exclude any maternal tissue potential cause: failure to exclude any maternal tissue causes cup detachment/pop-off.Harm 1: hematoma.Severity: 4.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "monitor".Harm 2: abrasion.Severity: 2.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "acceptable".Harm 3: fracture.Severity: 3.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "acceptable".Harm 4: laceration.Severity: 3.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "acceptable".Harm 5: death.Severity: 5.Potential cause: lack of attention, not qualified personnel.Probability of occurrence: 1.Risk is considered "monitor".Root cause analysis: a root cause could not be determine because the device was not returned for evaluation.User error and device malfunction cannot be ruled out as potential root causes.
Event or Problem Description
In the customers words: "scalp lesions after use on two babies" "the baby's scalp was almost torn off.The child had to be transferred to a neonatal unit after birth.He is now being monitored by a specialist for any neurological after-effects." follow ups have been attempted but to date no further information has been provided.

• Brand Name: KIWI VACUUM ASSISTED DELIVERY SYSTEM
• Common Device Name: FOETEL VACUUM ASSISTED DELIVERY DEVICE
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: zulmar molina ; 747 w 4170 s; murray, UT ; 8012606086
• MDR Report Key: 19037636
• Report Number: 1722684-2024-00006
• Device Sequence Number: 18189543
• Product Code: HDB
• UDI-Device Identifier: 00814247020635
• UDI-Public: 00814247020635
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K981260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/03/2024

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: 07/20/2025
• Device Model Number: VAC-6000ME
• Device Lot Number: 230998
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown