BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL SIGNS, INC.

    MDR report key: 2071858 · Received April 22, 2011

    Report

    Report Number
    MW5020390
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 22, 2011
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    CAI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    MY SON WENT FOR SURGERY AND ADULT CIRCLE BREATHING CIRCUIT HAD A BLOCKAGE DUE TO MFR'S ERROR. THE BLOCKAGE WAS A PIECE OF PLASTIC THAT WAS NEVER PUNCHED OUT; IT WAS TOWARD THE TUBING SIDE. OBVIOUSLY THE PIECE WAS NOT INSPECTED BY GE (VITAL SIGNS) (B)(6) LOT #11090B BEFORE BEING CLEARED FOR USE BY PTS, NOR DID THE HOSPITAL PROPERLY INSPECT PRODUCT PRIOR TO USING IT ON MY SON. MY SON WAS SCHEDULED FOR AN ELECTIVE SURGERY, HE ALMOST DIED ON FRIDAY. THE STRESS THIS HAS CAUSED ON MY FAMILY IS TREMENDOUS. THEY USED SEVERAL MEDICATIONS TO SUPPORT HIS HEART AS WELL AS EPINEPHRINE AND SEVERAL OTHER MEDICATIONS TO TRY TO CLEAR WHAT THEY THOUGHT WAS A BLOCKAGE, I HAVE A DETAILED REPORT FROM THE SURGERY ALSO I HAVE HAD SEVERAL MEETINGS WITH THEM AS WELL. INCIDENT IS CURRENTLY UNDER INVESTIGATION. MY SON WAS SUPPOSED TO HAVE A NERVE BLOCK AND DIDN'T AND HAS BEEN ON PERCOCET (WHICH IS A HIGHLY ADDICTIVE DRUG) FOR 6 DAYS. ALSO HE IS EXPERIENCING SEVERE HEADACHES AND CONSTANT FATIGUE, SINCE THIS EVENT. WE WILL FOLLOW UP WITH SPECIALIST TO CHECK HIS HEART AND THE SYMPTOMS HE IS CURRENTLY EXPERIENCING. I AS A MOTHER ALSO IN THE HEALTH CARE FIELD, AND CURRENTLY I AM EMPLOYED BY THE HOSPITAL I AM PLEADING WITH YOU TO TAKE IMMEDIATE ACTION IN RECALLING THIS PRODUCT. HOW MANY OF THESE DEFECTIVE PRODUCTS WILL BE USED BEFORE A RECALL IS PUT IN PLACE? I CERTAINLY HOPE NO ONE HAS TO EVER EXPERIENCE WHAT I AM FEELING TODAY THE UNCERTAINTIES OF WHAT THE LONG TERM EFFECTS WILL BE ON MY SON. HOW CAN A MFR MAKE SUCH A CARELESS MISTAKE? WHY DIDN'T THE HOSP FOLLOW PROCEDURE AND INSPECT THE PRODUCT BEFORE USE? THESE ARE QUESTIONS THAT HAVE REPLAYED OVER AND OVER AGAIN. I HAVE NOT SLEPT IN DAYS, I WILL NOT REST UNTIL THIS IS ADDRESSED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL SIGNS, INC. ADULT CIRCLE BREATHING CIRCUIT CAI VITAL SIGNS, INC. A4F12014 11090B

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening| S