BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEST MODEL

    MDR report key: 3800232 · Received April 30, 2014

    Report

    Report Number
    3008145987-2014-00002
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 19, 2014
    Report Date
    April 1, 2014
    Product Code
    BYI
    PMA / PMN Number
    K024309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    I CALLED (B)(6) THE PATIENT, TO DISCUSS THE ALLEGATION OF A CHEST PAIN AND SHORTNESS OF BREATH. (B)(6) BELIEVES THE VEST WAS WORKING PROPERLY AND THAT HE SHOULD HAVE PROBABLY NOT BEEN WEARING THE VEST WITH HIS MEDICAL CONDITION. (B)(6) STATED HE WENT INTO THE HOSPITAL FOR A BRONCHOSCOPY ON FRIDAY (B)(6) 2014. HE RETURNED HOME AND WAS READMITTED TO THE EMERGENCY ROOM SATURDAY (B)(6) 2014. HE HAD NOT BEEN WEARING THE VEST AT ANY POINT. HIS TEST CAME BACK NEGATIVE ON SATURDAY AND WAS RELEASED. HE STATED HE FELT BETTER ON TUESDAY (B)(6) 2014, HE USED THE VEST THAT EVENING AND INTO WEDNESDAY MORNING. LATER THAT DAY HIS SYMPTOMS OF CHEST PAIN AND SHORTNESS OF BREATH RETURNED. PATIENT WAS OUT OF TOWN BUT WENT DIRECTLY TO THE EMERGENCY ROOM AFTER RETURNING HOME THURSDAY (B)(6) 2014. AT THIS POINT HE WAS DIAGNOSED WITH A PLEURAL EFFUSION AND WAS ADMITTED TO THE HOSPITAL FOR SIX DAYS AND HAD CHEST TUBES DUE TO HIS PRIOR CONDITION AND DID NOT BELIEVE THE VEST WAS CAUSING THE INJURY. SINCE BEING RELEASED FROM THE HOSPITAL HE HAS NOT WORN THE VEST DUE TO THE SUTURES ON HIS SIDE. 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. THERE IS NO CLEAR CAUSAL RELATION BETWEEN THE USE OF THE VEST AND THE DEVELOPMENT OF A PLEURAL EFFUSION, IT WAS MOST LIKELY DUE TO HIS UNDERLYING DISEASE. THERE WAS NO EVIDENCE OF A MALFUNCTION AND THE DEVICE PERFORMED AS INTENDED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FORM A PATIENT STATING HE WAS EXPERIENCING CHEST PAIN AND SHORTNESS OF BREATH. THE VEST WAS LOCATED IN THEIR HOME. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258955 VEST MODEL THE VEST BYI P105C

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization