BEACH CHAIR POSITIONER

Additional Manufacturer Narrative

THE CUSTOMER HAS RECEIVED A REPLACEMENT DEVICE. THE DEVICE INVOLVED IN THIS EVENT IS BEING RETURNED TO THE MANUFACTURER. INVESTIGATION IS ONGOING. HILLROM WILL GATHER ADDITIONAL INFORMATION ON THE CIRCUMSTANCES THAT LEAD TO THE EVENT. ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION WILL BE SUBMITTED IN A FINAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN INTUBATED PATIENT THE BACKBOARD OF A BEACH CHAIR SHOULDER POSITIONER BROKE IN HALF CAUSING THE PATIENT TO FALL BACKWARDS. SURGICAL STAFF IMMEDIATELY CAUGHT THE PATIENT LEADING TO NO INJURY/HARM AND IT IS ADDITIONALLY NOTED THERE WAS NO DELAY IN CARE FROM THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

Additional Manufacturer Narrative

ON THE 30TH OF JUNE 2022, ARTHREX, WHO INFORMED HILLROM OF THIS EVENT, COMMUNICATED THAT THEIR CUSTOMER WOULD NOT BE RETURNING THIS DEVICE FOR REPAIR / EVALUATION. THE BEACH CHAIR SHOULDER POSITIONER IS DESIGNED TO POSITION AND SUPPORT THE PATIENT¿S HEAD AND TORSO IN A VARIETY OF SURGICAL PROCEDURES INCLUDED, BUT NOT LIMITED TO ORTHOPEDIC SURGERIES LIKE, ROTATOR CUFF, TOTAL SHOULDER, REVERSE TOTAL SHOULDER, SLAP REPAIR AND OTHER SHOULDER SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. DO NOT EXCEED 500 LBS. (226 KG) PATIENT WEIGHT. THE SERIAL NUMBER SHOWS THAT THE DEVICE WAS MANUFACTURED IN DECEMBER OF 2014. THIS DEVICE WAS NOT RECEIVED FOR EVALUATION / REPAIR. SINCE THE DEVICE WAS NOT RETURNED, THE ALLEGATION COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE MOST LIKELY ROOT CAUSE OF THE BACKBOARD BREAKING WOULD BE A COMBINATION OF WEAR AND TEAR OF THE DEVICE (DUE TO THE DEVICE BEING OVER TWO YEARS BEYOND ITS DESIGN LIFE) AND CUSTOMER INDUCED DAMAGE. ALTHOUGH THERE WAS NO PATIENT OR CAREGIVER INJURY OR DELAY IN CARE FROM THE REPORTED EVENT, HILLROM CONSIDERS THIS A REPORTABLE EVENT BECAUSE OF THE LIMITED INFORMATION AVAILABLE ON THE MALFUNCTION AND THE POTENTIAL FOR A SERIOUS INJURY IF IT HAD TO RECUR. H3 OTHER TEXT : DEVICE NOT RETURNED BY THE CUSTOMER.

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING AN INTUBATED PATIENT THE BACKBOARD OF A BEACH CHAIR SHOULDER POSITIONER BROKE IN HALF CAUSING THE PATIENT TO FALL BACKWARDS. SURGICAL STAFF IMMEDIATELY CAUGHT THE PATIENT LEADING TO NO INJURY/HARM AND IT IS ADDITIONALLY NOTED THERE WAS NO DELAY IN CARE FROM THE EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT (B)(4).