BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONDUCTIVE RESTRAINT STRAP

    MDR report key: 592264 · Received April 13, 2005

    Report

    Report Number
    MW1035198
    Event Type
    Malfunction
    Date Received
    April 13, 2005
    Date of Event
    December 28, 2004
    Report Date
    April 7, 2005
    Manufacturer
    STERIS
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER SURGERY THE PT REMAINED ON THE OR TABLE IN THE OR ROOM. NURSE WENT TO GET THE GURNEY AT WHICH TIME PT FELL OFF OR TABLE ONTO FLOOR. IT WAS THOUGHT THAT THE HOOK CAME LOOSE & THE PT MOVED, TURNED & FELL OFF THE TABLE. SINCE THIS INCIDENT THE HOOK HAS BEEN REMOVED FROM THE STRAP.

    Description of Event or Problem · 1

    1. THE MODEL NUMBER AND/OR CATALOG NUMBER OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT. CONDUCTIVE RESTRAINT STRAP - STANDARD LENGTH 66" (168CM); CATALOG # BF08-800. 2. THE MANUFACTURING LOT AND/OR SERIAL NUMBER OF THE DEVICE LISTED IN THE MEDICAL DEVICE REPORT. LIKE MANY OTHER ACCESSORIES, THIS DEVICE LISTED IS NOT A SERIALIZED ITEM. THE CURRENT SUPPLIER REPORTS THAT THEY HAVE INSTRUCTED THEIR QC DEPARTMENT TO BEGIN ADDING THE SAME LOT # INFO TO FUTURE ORDERS OF THESE STRAPS. 3. A MORE COMPLETE DESCRIPTION OF THE INCIDENT DESCRIBED IN THE MEDICAL DEVICE REPORT INCLUDING RELEVANT EVENTS PRIOR TO AND SUBSEQUENT TO THE ACTUAL INCIDENT. THE RECEIPT OF THE MEDWATCH REPORT FROM FDA IN 2005 WAS THE FIRST NOTIFICATION OF THIS EVENT RECEIVED BY STERIS. THE FACILITY DID NOT CONTACT STERIS DIRECTLY REGARDING THIS EVENT. ACCORDING TO THE EVENT DESCRIPTION PROVIDED BY THE HOSPITAL, THE PT WAS LEFT UNATTENDED (PER THE INITIAL REPORTER, THE ANESTHESIOLOGIST HAD TURNED HIS BACK TO THE PT) WHILE THE NURSE WENT TO RETRIEVE THE GURNEY/STRETCHER IN ORDER TO TRANSFER THE PT FROM THE SURGICAL TABLE AND INTO RECOVERY. IF THIS WAS INDEED THE CASE, THEN THE HOSPITAL ERRED IN LEAVING AN ANESTHETIZED PT NOT PROPERLY ATTENDED. PATIENTS HAVING GENERAL ANESTHESIA OR CENTRAL NEURAXIS BLOCKS (SPINALS OR EPIDURALS) SHOULD NOT BE LEFT ALONE UNTIL THEY ARE SAFELY BACK ON THE WARD AFTER RECOVERY FROM THE ANESTHETIC. THE PT SHOULD BE STABLE BEFORE BEING LEFT ALONE. 4. ANY EVALUATION OF OTHER INFORMATION USED BY YOUR FIRM TO DETERMINE WHETHER THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT ARE OR ARE NOT ATTRIBUTABLE TO THE DEVICE. THIS PRODUCT HAS BEEN IN USE AS A SURGICAL TABLE ACCESSORY SINCE AT LEAST 1979. DURING A TELEPHONE CONVERSATION WITH THE INITIAL REPORTER IN 2005 AT APPROX 1:45PM, THE FACILITY REPORTED THAT THEY HAVE USED THIS PRODUCT FOR A NUMBER OF YEARS AND THIS WAS IN HER OPINION AN UNUSUAL EVENT WITH THIS STRAP. THE INITIAL REPORTER ALSO STATED THAT THEY DO NOT KNOW AND MAY NEVER KNOW WHAT ACTUALLY HAPPENED SINCE THE ANESTHESIOLOGIST HAD HIS BACK TURNED AND THE NURSE WAS OUT OF THE ROOM, THERE IS NO EYE WITNESS OBSERVATION OF HOW THE HOOK CAME LOOSE OR IF THE PT MANAGED TO RELEASE THE BUCKLE. WHEN ASKED WHY STERIS WAS NOT INFORMED SHE STATED THAT THEY DID NOT INFORM STERIS AND THEY SIMPLY COMPLETED A MEDWATCH. NO OTHER EXPLANATION WAS GIVEN. A STERIS REPRESENTATIVE VISITED THE ACCOUNT IN 2005. THE REPORT FROM THIS INDIVIDUAL STATED THAT ACCORDING TO THE FACILITY REPORTER, "THERE WERE NO REPORTED OR OBSERVED INJURIES. THE PT WAS TAKEN CARE OF IN THE O.R. AND THERE HAS BEEN NO FURTHER FOLLOW-UP OR PT CONTACT. THERE WERE NO WITNESSES, DOCTOR AND O.R. TECH WERE IN THE ROOM BUT THEIR BACKS WERE TO THE PT. THE STRAP PRESENTED WAS INTACT WITH NO DAMAGE. THE O.R. TABLES ARE SERVICED BY A THIRD PARTY SERVICE PROVIDER STS." THE HOOKS USED ON THIS STRAP ARE FABRICATED FROM STAINLESS STEEL ROUND ROD STOCK WITH A ROUND HOOK WHICH GRASPS THE TABLE SIDE RAIL WHEN SECURED BY ADJUSTING OR TIGHTENING THE STRAP AROUND THE PT. ADJUSTMENT IS ACHIEVED BY PULLING THE STRAP AND TIGHTENING THE "AIRPLANE BUCKLE" ON THE STRAP. THE STRAP ITSELF IS MADE OF BLACK RUBBER WITH A CLOTH INNER LAYER. THE SUPPLIER OF THE STRAP WAS PROFEX MEDICAL PRODUCTS WHICH PRODUCES MEDICAL PRODUCT FOR OEM'S SUCH AS STERIS, AND HAS BEEN IN BUSINESS SINCE 1938. THERE HAS BEEN NO INDICATION FROM A REVIEW OF COMPLAINTS THAT THERE IS A TREND INDICATING A PRODUCT PROBLEM. 5. DESCRIPTION OF ANY DESIGN CHANGES OR MODIFICATIONS IN THE DEVICE SINCE FIRST MARKETED THAT MAY BE RELATED TO THE EVENT INCLUDING ANY STERILIZATION CHANGES, IF APPLICABLE, AND THE DATE OF THE CHANGES. AS STATED EARLIER THIS PRODUCT HAS BEEN MARKETED SINCE AT LEAST 1979, AND THERE DOES NOT APPEAR TO HAVE BEEN ANY CHANGES TO THE DEVICE THAT ARE RELATED TO THE EVENT. 6. IT IS NOT CLEAR WHICH HOOK CAME OFF FROM WHAT PART OF THE BED. NEED MORE DETAIL ON THE EVENT ITSELF. SEE THE RESPONSE TO QUESTION 3 FOR DETAILS ON THE ACTUAL INCIDENT AS REPORTED TO STERIS BY THE INITIAL REPORTER. A PHOTOGRAPH OF THE PRODUCT IS ATTACHED FOR YOUR REFERENCE. AS YOU CAN SEE, THE HOOK ATTACHES TO THE TABLE SIDE RAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONDUCTIVE RESTRAINT STRAP RESTRAINT FQO STERIS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other