CFLEX POLAR HD POS DEVICE ONLY
Report
- Report Number
- 3010216206-2024-00004
- Event Type
- Malfunction
- Date Received
- May 1, 2024
- Date of Event
- April 8, 2024
- Report Date
- June 11, 2024
- Manufacturer
- ALLEN MEDICAL SYSTEMS
- Product Code
- CCX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE DEVICE WAS INSPECTED BY THE HILLROM ENGINEERING AND REPAIR TEAM. DURING EVALUATION, IT WAS NOTED THE BELLEVILLE WASHERS WERE WORN OUT AND REPORTED EVENT WAS CONFIRMED. 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. 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 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 RETURN OF THE DEVICE FOR INSPECTION IS STILL IN PROCESS. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE DEVICE AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
IT WAS REPORTED THAT DURING USE OF A C-FLEX POLAR HEAD POSITIONER THE DEVICE MOVED EVEN WHEN LOCKED INTO PLACE. IT WAS NOTED PATIENT'S HEAD SLIPPED TWICE PRIOR TO INCISION OF PROCEDURE. THERE WAS NO ALLEGATION OF INJURY FROM THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
IT WAS REPORTED THAT DURING USE OF A C-FLEX POLAR HEAD POSITIONER THE DEVICE MOVED EVEN WHEN LOCKED INTO PLACE. IT WAS NOTED PATIENT'S HEAD SLIPPED TWICE PRIOR TO INCISION OF PROCEDURE. THERE WAS NO ALLEGATION OF INJURY FROM THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2081157 | CFLEX POLAR HD POS DEVICE ONLY | C-FLEX HEAD POSITIONING SYSTEM | CCX | ALLEN MEDICAL SYSTEMS | A-70701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |