ALLEN LIFT ASSIST BEACH CHAIR

Description of Event or Problem

THE CUSTOMER INITIALLY REPORTED THAT THE BEACH CHAIR'S SUPPORT BROKE DURING SURGERY. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY AS A RESULT OF THIS EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

Additional Manufacturer Narrative

UPON TECHNICIAN INSPECTION, THE REPORTED EVENT WAS CONFIRMED AS BACKBOARD WAS FOUND BROKEN AS IT SHOWED SIGNS OF ABUSE. THE TECHNICIAN REPLACED THE BACKBOARD IN TO RESOLVE THE REPORTED EVENT. ALTHOUGH THE CUSTOMER CONFIRMED THERE WAS NO INJURY, NO CONTAMINATION OF THE STERILE FIELD AND THE PATIENT WAS NOT EXPOSED TO CROSS-CONTAMINATION, IF A SIMILAR MALFUNCTION HAD TO RECUR IT WOULD LIKELY LEAD TO A SERIOUS INJURY OR DEATH. THEREFORE, BAXTER CONSIDERS THIS EVENT REPORTABLE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

THE CUSTOMER INITIALLY REPORTED THAT THE BEACH CHAIR'S SUPPORT BROKE DURING SURGERY, THE STERILE FIELD WAS COMPROMISED, AND THE PATIENT WAS EXPOSED TO CROSS CONTAMINATION. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY AS A RESULT OF THIS EVENT. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

Additional Manufacturer Narrative

THE CUSTOMER INITIALLY REPORTED THAT THE BEACH CHAIR'S SUPPORT BROKE DURING SURGERY, THE STERILE FIELD WAS COMPROMISED, AND THE PATIENT WAS EXPOSED TO CROSS CONTAMINATION. THERE WAS NO ALLEGATION OF PATIENT OR CAREGIVER INJURY AS A RESULT OF THIS EVENT. THE BEACH CHAIR SHOULDER POSITIONER IS DESIGNED TO POSITION AND SUPPORT THE PATIENT¿S HEAD AND TORSO IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO ORTHOPAEDIC 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. THIS DEVICE IS INTENDED TO BE USED WITH PATIENTS THAT DO NOT EXCEED THE SAFE WORKING LOAD OF 500 LBS (226 KG). IT IS RECOMMENDED TO NOT APPLY EXCESSIVE FORCE TO SHOULDER PANEL (61 LBS (27 KG) WEIGHT LIMIT). DURING A FOLLOW-UP CALL THE CUSTOMER CONFIRMED THE CENTER OF THE BEACH CHAIR'S SUPPORT CRACKED AND THE PATIENT SLID SLIGHTLY TO THE LEFT BUT DID NOT FALL. IT WAS NOTED THAT THE SURGICAL TEAM SUPPORTED THE BEACH CHAIR USING TAPE AND WAS ABLE TO COMPLETE THE CASE WITHOUT FURTHER COMPLICATION. IT WAS ALSO CONFIRMED THERE WAS NO INJURY, NO CONTAMINATION OF THE STERILE FIELD AND THE PATIENT WAS NOT EXPOSED TO CROSS-CONTAMINATION. THE CUSTOMER EXAMINED THE DEVICE AND STATED THEY WERE UNABLE TO DETERMINE IF THE EVENT WAS CAUSED BY WEAR AND TEAR OF THE DEVICE OR A WEIGHT LIMIT ISSUE. HOWEVER, THE CUSTOMER COULD NOT PROVIDE THE PATIENT'S WEIGHT. ALTHOUGH THE CUSTOMER CONFIRMED THERE WAS NO INJURY, NO CONTAMINATION OF THE STERILE FIELD AND THE PATIENT WAS NOT EXPOSED TO CROSS-CONTAMINATION, IF A SIMILAR MALFUNCTION HAD TO RECUR IT WOULD LIKELY LEAD TO A SERIOUS INJURY OR DEATH. THE ROOT CAUSE OF THE REPORTED MALFUNCTION WAS NOT YET DETERMINED. AN INSPECTION OF THE DEVICE IS CURRENTLY BEING ARRANGED, ALL ADDITIONAL AND RELEVANT INFORMATION THAT IS IDENTIFIED FOLLOWING COMPLETION OF THE INSPECTION WILL BE SUBMITTED IN A FINAL REPORT.