D
Patient 1
ON (B)(6) 2016 WINCO MFG., LLC (CUSTOMER SERVICE) WAS CONTACTED BY (B)(6), TECHNICAL SERVICES OPERATIONS COORDINATOR. SHE INFORMED US THAT AN INJURY OCCURED WHILE A PATIENT WAS USING A SWING-AWAY ARM DESIGNER CARE CLINER, MODEL 6740-28-00-HM, SN (B)(4). MS. (B)(6) ALSO INFORMED US ((B)(6) 2016) THAT THEIR RISK MANAGER WOULD CONTACT US REGARDING HER INVESTIGATION. EVENT DESCRIPTION: AS THE PATIENT WAS RE-POSITIONING HIMSELF IN THE DIALYSIS CHAIR, THE ARM UNEXPECTEDLY SWUNG OPEN AND HE FELL, FRACTURING HIS HIP. HE REQUIRED HOSPITALIZATION AND HIP SURGERY. THERE WAS NO INFORMATION GIVEN ON THE OUTCOME OF THE PATIENT'S CONDITION AFTER TREATMENT. ON (B)(4) 2016 WE SPOKE WITH (B)(6) - RISK MANAGER, (B)(6) - TECHNICAL SERVICES OPERATIONS COORDINATOR AND (B)(6) - TECHNICIAN. THEY WERE UNABLE TO DUPLICATE THE CONDITION DESCRIBED AND SAID THE LATCH DID NOT SEEM TO FUNCTION WELL. THEY ADMITTED THAT THE LEFT ARM NEEDED TO BE LIFTED TO CLOSE TIGHTLY AND THE GAP IS VISIBLY UNEVEN COMPARED TO THE RIGHT SIDE ARM. THEY ALSO STATED THAT THEY DID NOT KNOW THAT THEY SHOULD NOT SIT ON OR PUT WEIGHT ON SWING ARMS IN THE OPEN POSITION. MS (B)(6) INFORMED US TO CONTACT (B)(6) FOR FURTHER QUESTIONS AND FOR PERMISSION TO PICK UP THE CHAIR FOR WINCO TO EVALUATE. ON 09/29/2016 THE CHAIR WAS RETURNED TO WINCO WHERE ENGINEERING & QUALITY PERFORMED AN INSPECTION ON IT. THE HINGE BOLT WAS LOOSE ON THE LEFT SWING ARM CAUSING THE ARM TO DROOP DOWN FAR ENOUGH THAT THE STRICKER PIN WOULD NOT PROPERLY ENGAGE THE LATCH. THIS CONDITION WOULD ALLOW THE ARM TO SWING OUT UNEXPECTEDLY. LIFTING UP THE ARM WOULD ALLOW THE ARM TO LATCH PROPERLY. MOST LIKELY UNDERLYING CAUSE WAS THAT HARDWARE LOOSENED DUE TO FREQUENT USE AND TIME AND RECOMMENDED MAINTENANCE WAS NOT BEING PERFORMED AS POINTED OUT IN THE USER'S MANUAL. ALSO, THERE ARE INDICATIONS THAT EXCESSIVE WEIGHT WAS PLACED ON OPENED SWING ARMS CAUSING THE ARM TO DROOP. THE CHAIR SHOULD HAVE ALSO BEEN REMOVED FROM SERVICE AS SOON AS THIS CONDITION WAS NOTICED BY STAFF IN ACCORDANCE WITH INSTRUCTIONS IN THE USER'S MANUAL. THE SWING ARM HINGE WAS BENT AND LOOSE, HOWEVER, LATCH ASSEMBLY FUNCTIONED PROPERLY.