BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITYVAC II VACUUM PUMP

    MDR report key: 219170 · Received March 23, 1999

    Report

    Report Number
    1450530-1998-00002
    Event Type
    Injury
    Date Received
    March 23, 1999
    Date of Event
    August 10, 1998
    Report Date
    September 29, 1998
    Manufacturer
    PRISM TECHNOLOGIES, INC.
    Product Code
    HDB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A FULL TERM PREGNANT WOMAN CAME TO LABOR AND DELIVERY DUE TO ACTIVE LABOR. AFTER 12 HRS OF LABOR AND SEVERAL RE-DOSES OF ANESTHESIA, VACUUM WAS USED DUE TO INEFFECTIVE PUSHING AND MATERNAL EXHAUSTION. BABY BOY WAS DELIVERED IN RESPIRATORY DISTERSS THAT RESOLVED AFTER INTERVENTION. PRIOR TO USING THE VACUUM, THERE WAS NO CONTRAINDICATION FOR ITS USE. PRESSURE GAUGE USED WAS BETWEEN 36 - 58 CM HG X 1 ATTEMPTS. BABY HAD MILD BRUISUNG ON THE CHIN, HEMATOMA AND CAPUT SUCCEDENEUM AT OCCIPITAL UREA. PECT DONE AFTER 2 DAYS SINCE PTOSIS OF THE LEFT EYE WAS OBSERVED AND REVEALED INTERVENTIRCULAR HEMORRHAGE. BABY WAS TRANSFERRED TO A HIGHER LEVEL OF CARE FACILITY. DEVICE PROBLEM: 1. POTENTIAL FOR IMPROPER USE. 2. UNABLE TO SUBSTANTIATE PROPER/IMPROPER USE DUE TO INADEQUQATE DOCUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITYVAC II VACUUM PUMP MITYVAC OBSTETRICAL VACUUM DELIVERY SYSTEM HDB PRISM TECHNOLOGIES, INC. U.S. PAT # 5.217.354 MD 6130

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DAY Life Threatening MITYVAC OBSTETRICAL VACUUM DELIVERY KIT.