inforMED
MalfunctionGBB

SHOULDER CHAIR ASSEMBLY

Received Mar 9, 2023 · Event occurred Oct 6, 2022

Report 1043572-2023-00061 · MDR key 16514295

Device

Generic name

Shoulder Chair

Model number

SHOULDER CHAIR

Catalog number

BF594

Product problems

  • Improper or Incorrect Procedure or Method
  • Improper or Incorrect Procedure or Method

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

STERIS OFFERED IN-SERVICE TRAINING ON THE PROPER USE OF THE SHOULDER CHAIR THAT IS UTILIZED WITH STERIS SURGICAL TABLES HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

THROUGH FOLLOW-UP WITH USER FACILITY PERSONNEL, STERIS WAS ABLE TO CONFIRM THAT THE PATIENT WAS POSITIONED ON A SHOULDER CHAIR ASSEMBLY THAT WAS BEING UTILIZED WITH A STERIS 5085 SURGICAL TABLE DURING THE TIME OF THE REPORTED EVENT. A STERIS CLINICAL SUPPORT REPRESENTATIVE AND A STERIS PROCEDURAL SALES REPRESENTATIVE CONFIRMED THAT NO ISSUES WERE NOTED WITH THE SHOULDER CHAIR ASSEMBLY, OR 5085 SURGICAL TABLE FOLLOWING THE REPORTED EVENT AND FOUND THE DEVICES TO BE OPERATING PROPERLY. THE STERIS INSTRUCTIONS FOR USE POWERLIFT BEACH CHAIR FOR CMAX, STERIS 4085 GENERAL, STERIS 5085 SRT, STERIS 5085 GENERAL AND STERIS 5085 HARMONY SURGICAL TABLES (REV A) P056404-439 STATES IN PATIENT POSITIONING; WARNING - PERSONAL INJURY HAZARD: WHEN POSITIONING THE PATIENT ON THE POWERLIFT BEACH CHAIR, ENSURE THE PATIENT'S HEAD, ARMS AND TORSO ARE SUPPORTED. TO ENSURE PATIENT STABILITY, BEFORE ARTICULATING SURGICAL TABLE OR POWERLIFT BEACH CHAIR, SECURE PATIENT IN ACCORDANCE WITH RECOMMENDED POSITIONING PRACTICES. PREVENT POSSIBLE INJURY TO PATIENT'S HEAD AND NECK. BEFORE SECURING FOREHEAD AND CHIN STRAPS, ENSURE CORRECT ALIGNMENT OF PATIENT'S HEAD AND BODY. SUPPORT PATIENT'S HEAD WHENEVER ADJUSTING HEADREST. THE STERIS REPRESENTATIVES OFFERED IN-SERVICE TRAINING ON THE PROPER USE OF THE SHOULDER CHAIR THAT IS UTILIZED WITH STERIS SURGICAL TABLES AND THE USER FACILITY ACCEPTED. STERIS IS WORKING WITH THE USER FACILITY TO SCHEDULE A DATE IN MARCH 2023. THE SHOULDER CHAIR ASSEMBLY AND 5085 SURGICAL TABLE WERE RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED VIA MEDWATCH REPORT (B)(4) THAT DURING A PATIENT PROCEDURE THE PATIENT'S HEAD SLID OUT OF THE POSITIONER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO INJURIES WERE REPORTED.