BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTROLLER, VEST 105

    MDR report key: 3800231 · Received April 30, 2014

    Report

    Report Number
    3008145987-2014-00003
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    January 20, 2014
    Report Date
    March 31, 2014
    Product Code
    BYI
    PMA / PMN Number
    K024309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE HOSPITAL THE PATIENT'S BLOOD PRESSURE WAS 60/30 AND HE WAS TRANSFUSED WITH THREE UNITS OF BLOOD. EMERGENCY LAPAROSCOPIC SURGERY WAS PERFORMED TO REPAIR A TORN ARTERY IN HI ABDOMEN. THE PATIENT WAS APPROXIMATELY TWO WEEKS STATUS POST FUNDOPLICATION. HE HAS A HISTORY OF BEING SPECIAL NEEDS, SEIZURE DISORDER AND GERD. HE WAS USING THE VEST FOR PULMONARY ISSUES RELATED TO THE GERD. MEDICATIONS INCLUDE MIRALAX AND SEVERAL ANTICONVULSANTS. THE VEST HAS BEEN IN USE SINCE (B)(6) 2013. A HILL-ROM REPRESENTATIVE CALLED THE PATIENT'S FATHER TO DISCUSS THE ALLEGATION OF AN ARTERY RUPTURING. THE FATHER STATED THAT IN HIS DOCTOR'S REPORT STATES THAT THE VEST CAUSED THE RUPTURE. HIS SON IS A SPECIAL NEEDS (B)(6) OLD BOY AND HAS NOT BEEN THE SAME SINCE THIS INCIDENT. THE FATHER DID STATE THAT HE DOES NOT GIVE THE VEST TREATMENTS BUT THIS WAS ALSO NOT THE FIRST TIME HIS SON HAS USED THE VEST. THE FATHER WOULD NOT RERELEASE ANY FURTHER INFORMATION TILL HE SEEKS LEGAL COUNSEL. THE VEST HAS NOT BEEN USED SINCE THE INCIDENT. THE VEST WAS SENT BACK TO HILL-ROM FOR INVESTIGATION AND THE ENGINEERING INVESTIGATION CONCLUDED THAT THE VEST PASSED ALL PERFORMANCE TESTING AND DID FUNCTION AS DESIGN.

    Description of Event or Problem · 1

    THE PATIENT'S FATHER REPORTED THAT DURING A TREATMENT WITH THE VEST, HIS CHILD WHO DOES NOT VERBALLY COMMUNICATE, APPEARED TO CRAMP AND HIS MOUTH WAS OPENED WIDE. HE LAID HIM DOWN AND WITHIN A COUPLE OF HOURS, HE TOOK HIM TO THE HOSPITAL. THE VEST WAS BEING ADMINISTERED IN THE PATIENT'S HOME BY THE CAREGIVER (FATHER). THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4). RUPTURE ARTERY IS A POTENTIAL COMPLICATION OF A FUNDOPLICATION SURGICAL PROCEDURE. THERE IS NO CLEAR CAUSAL RELATIONSHIP BETWEEN THE USE OF THE VEST AND THE RUPTURE OF THE ARTERY. THERE WAS NO EVIDENCE OF A MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258668 CONTROLLER, VEST 105 THE VEST BYI P105CM

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| L