BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIWI VACUUM DELIVERY SYSTEM

    MDR report key: 24954557 · Received April 22, 2026

    Report

    Report Number
    1722684-2026-00010
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 22, 2026
    Manufacturer
    CLINICAL INNOVATIONS, LLC
    Product Code
    HDB
    UDI-DI
    00814247020659
    PMA / PMN Number
    K981260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIVE ACTION HAS BEEN OPENED TO INVESTIGATE THE FAILURE MODE. ADDITIONALLY, FIELD ACTIONS ARE UNDERWAY. CUSTOMER HAS BEEN CONTACTED FOR ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION FROM USER IS AS FOLLOWS: "13 APR 2026: UPDATED INFORMATION: "ONE OF THESE BATCHES": 251652, 250956, 251597. "OUTSIDE PAPERWORK WAS DISCARDED AND NOT ABLE TO BE RETRIEVED." INCIDENT DESCRIPTION: BABY WAS DELIVERED AT 41+3 WEEKS FOLLOWING AN UNCOMPLICATED ANTENATAL COURSE. THE BABY WAS BORN IN POOR CONDITION AFTER FETAL BRADYCARDIA AND A PROLONGED INSTRUMENTAL DELIVERY DUE TO A SNAPPED KIWI, MEETING CRITERIA A AND B FOR THERAPEUTIC HYPOTHERMIA. SHE WAS INTUBATED AND VENTILATED SHORTLY AFTER BIRTH, TRANSFERRED TO HEARTLANDS HOSPITAL, BIRMINGHAM FOR COOLING ON DAY OF BIRTH, AND REPATRIATED TO KMH ON (B)(6) 2026. THERAPEUTIC HYPOTHERMIA WAS COMPLETED, AND SHE WAS REWARMED ON 20/03. SHE REQUIRED MECHANICAL VENTILATION UNTIL 20/03, WHEN SHE WAS SUCCESSFULLY EXTUBATED. SINCE THEN, SHE HAS BEEN SELF-VENTILATING IN AIR. SHE WAS INITIALLY SCREENED FOR SEPSIS; INFECTION MARKERS WERE NORMAL AND BLOOD CULTURES WERE STERILE, SO ANTIBIOTICS WERE DISCONTINUED. SHE HAS REMAINED CLINICALLY STABLE WITH NORMAL NEUROLOGICAL EXAMINATIONS. MRI PERFORMED SHOWED RESTRICTED DIFFUSION OF THE INTERNAL CAPSULE CONSISTENT WITH MODERATE TO SEVERE HIE. IT IS LIKELY THAT SHE MAY DEVELOP CEREBRAL PALSY IN TIME BUT IT IS DIFFICULT TO KNOW TO WHAT EXTENT THIS WILL AFFECT HER. SHE WILL HAVE ONGOING PHYSIOTHERAPY AS AN OUTPATIENT TO MONITOR TONE CLOSELY AND ENSURE EARLY RECOGNITION OF CONCERNS. PATIENT CONDITION: PATIENT WAS DISCHARGED. DEVICE EVENT DESCRIPTION: INITIAL KIWI SNAPPED ON 1ST PULL. 2ND KIWI APPLIED WHICH POPPED OFF HEAD. PATIENT WAS TRANSFERRED TO THEATRE TO CONTINUE DELIVERY WHICH CAUSED A DELAY IN DELIVERY. INDICATION FOR PRODUCT: INSTRUMENTAL DELIVERY REQUIRED DUE TO FETAL BRADYCARDIA. DESCRIBE EVENT OR PROBLEM IN DETAIL: INSTRUMENT APPLIED TO FETAL HEAD TO AID DELIVERY. 1ST INSTRUMENT BROKE DURING USE AND WAS REMOVED. A SECOND CUP WAS APPLIED WHICH POPPED OFF DURING USE. THE PATIENT WAS TRANSFERRED TO THEATRE FOR ANOTHER METHOD OF ASSISTED DELIVERY. THE PATIENT DELIVERED WITHOUT ASSISTANCE ON ARRIVAL IN THEATRE. OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: NIL RELEVANT UNCOMPLICATED ANTENATAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327837 KIWI VACUUM DELIVERY SYSTEM FOETEL VACUUM ASSISTED DELIVERY DEVICE HDB CLINICAL INNOVATIONS, LLC VAC-6000MTE 00814247020659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization