BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FLEX POLAR HEAD POSITNR- DEVICE ONLY

    MDR report key: 13939421 · Received March 29, 2022

    Report

    Report Number
    3010216206-2022-00001
    Event Type
    Malfunction
    Date Received
    March 29, 2022
    Date of Event
    March 1, 2022
    Report Date
    March 29, 2022
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    CCX
    UDI-DI
    00615521002701
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE C-FLEX HEAD POSITIONING SYSTEM CAN BE USED IN ALL TYPES OF SPINAL SURGERY, GIVING SURGEONS AND ANESTHESIOLOGISTS PRECISE CONTROL OVER THE HEAD AND CERVICAL SPINE. THE ¿SQUEEZE AND POSITION¿ TECHNOLOGY SUPPORTS EXACT SET UP AND READJUSTMENTS INTRAOPERATIVELY. VERSATILITY IS PROVIDED BY THE ABILITY TO USE THE SYSTEM WITH HEADRESTS OR WITH SKULL CLAMPS, THE QUICK-CONNECT COUPLER MAKING CONNECTING TO A SKULL CLAMP QUICK AND EASY. AN EXTENSIVE RANGE OF MOTION MAKES THE C-FLEX SYSTEM IDEAL FOR USE WITH EXTREMELY KYPHOTIC PATIENTS, ANTERIOR ARTIFICIAL DISCS AND LATERAL PROCEDURES. THE C-FLEX HEAD POSITIONING SYSTEM WAS REPAIRED ON SITE BY A FIELD TECHNICIAN WHERE IT WAS DETERMINED THAT THE SYSTEM MECHANISM WAS BROKEN. THE BELLOWS AND MIRROR KIT WERE REPLACED AND THE JOINTS WERE DEGREASED AFTER WHICH THE DEVICE FUNCTIONAL TESTING. THE C-FLEX HEAD POSITIONER IS COMPATIBLE FOR USE WITH THE ALLEN ADVANCE TABLE AND DESIGNED TO POSITION AND SUPPORT THE PATIENT¿S HEAD IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO SPINE SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. INSTRUCTIONS FOR USE CAUTION FOR THIS POSITIONER INCLUDE THE FOLLOWING: (1) MAKE SURE THAT THE ALLEN C-FLEX IS FULLY LOCKED ONTO THE RAILS PRIOR TO LOADING A PATIENT, (2) PUSH HEAD MODULE IN UNTIL IT ¿CLICKS,¿ (3) TO PREVENT PATIENT AND/OR USER INJURY AND /OR EQUIPMENT DAMAGE, VERIFY THE DEVICE ATTACHING CLAMPS COMPLETELY TOUCH THE TABLE-SIDE RAILS AND ARE FIRMLY IN PLACE. TEST THE LOCKING MECHANISM TO ENSURE NO MOVEMENT WHEN ELEVATED OR PUSHED, (4) THE LATERAL-TO-PRONE ASSEMBLY DOES NOT SUPPORT THE PATIENT¿S HEAD. A CAREGIVER MUST SUPPORT THE PATIENT¿S HEAD DURING THE LATERAL-TO-PRONE ROTATION AND MAINTAIN CORRECT HEAD POSITION. PATIENT INJURY CAN OCCUR. A BRUISE OR HEMATOMA IS AN INJURY TO TISSUES WITH SKIN DISCOLORATION AND WITHOUT BREAKAGE OF SKIN. BLOOD FROM THE BROKEN VESSELS ACCUMULATES IN SURROUNDING TISSUES, WHICH MAY PRODUCE PAIN, SWELLING, TENDERNESS, AND DISCOLORATION OF THE SKIN. MOST BRUISES/HEMATOMAS HEAL WITHOUT TREATMENT AND ARE THEREFORE NOT CONSIDERED A SERIOUS INJURY. A LACERATION IS A DISRUPTION OF THE SKIN, COMMONLY CALLED A CUT, AND CAN HAVE CLEAN STRAIGHT EDGES OR JAGGED EDGES. A SUPERFICIAL LACERATION INVOLVES ONLY THE SKIN, AND BECAUSE THERE IS NO PENETRATION OF MAJOR BLOOD VESSELS, BLEEDING WILL USUALLY STOP WITH THE APPLICATION OF PRESSURE WITHIN A FEW MINUTES. SUPERFICIAL LACERATIONS OR CUTS ARE NOT CONSIDERED A SERIOUS INJURY AS TREATMENT IS NOT REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. IN A SURGICAL ENVIRONMENT, A STEADY SURGICAL FIELD/SURGICAL SITE IS IMPERATIVE. AS A PRO-ACTIVE AND PATIENT SAFETY APPROACH THE SURGICAL TEAMS SHOULD ALWAYS INSPECT/ TEST PRODUCTS PRIOR TO PATIENT USE. IF THERE ARE ANY CONCERNS ON FUNCTIONALITY, THE PRODUCT WOULD BE REMOVED FROM SERVICE OR REPAIR AND A BACKUP DEVICE USED. ALTHOUGH THIS EVENT DID NOT RESULT IN SERIOUS INJURY, HOWEVER, IT THIS EVENT WAS TO RECUR DURING A CRITICAL SURGICAL CASE THE UNINTENDED MOVEMENT OF THE SURGICAL TABLE COULD RESULT IN A SERIOUS INJURY THEREFORE THIS EVENT IS REPORTABLE. THE CUSTOMERS DEVICE WAS REPAIRED ONSITE AND IS FUNCTIONING AS DESIGNED, BASED ON THIS INFORMATION NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE USING THE C-FLEX HEAD POSITIONER DEVICE, THE DEVICE SUDDENLY DROPPED RESULTING IN THE UNINTENDED MOVEMENT OF THE PATIENT. PHOTOGRAPHS PROVIDED BY THE CUSTOMER SHOW THE PATIENT SUSTAINED A LACERATION ABOVE THE RIGHT EAR AND WHAT RESEMBLES A BRUISE ABOVE THE LEFT EAR. MEDICAL INTERVENTION FOR THE INJURY WAS NOT REPORTED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL DETAILS OF THE EVENT WERE UNSUCCESSFUL. THIS EVENT HAS BEEN CAPTURED UNDER HILLROM REF (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253106 C-FLEX POLAR HEAD POSITNR- DEVICE ONLY C-FLEX HEAD POSITIONING SYSTEM CCX ALLEN MEDICAL SYSTEMS A-70701 00615521002701

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown