SYSTEM 2000

Additional Manufacturer Narrative

ACCORDING TO THE INFORMATION GATHERED, AN ARJO SERVICE TECHNICIAN WAS INJURED WHILE PERFORMING ANNUAL PREVENTIVE MAINTENANCE OF THE SYSTEM 2000 BATHTUB AT THE CUSTOMER'S SITE. THE TOP OF THE CARTRIDGE POPPED OUT AND, WHILE ATTEMPTING TO REMOVE IT, THE TECHNICIAN INJURED HIS FOREARM ON THE INNER METAL PLATE THAT GOES ALONG THE BATHTUB. THE INJURY REQUIRED A SUTURE ON THE FOREARM. THE INNER METAL PLATE THAT GOES ALONG THE BATHTUB IS LOCATED INSIDE THE BATH PANEL AND IS ONLY ACCESSIBLE TO SERVICE TECHNICIANS WHILE INSPECTING OR REPAIRING THE DEVICE. THEREFORE, CAREGIVERS AND PATIENTS DO NOT HAVE ACCESS TO THIS COMPONENT. THE PHOTOGRAPHIC EVIDENCE AND INFORMATION GATHERED IN THE COURSE OF THIS INVESTIGATION WERE CONSULTED WITH THE TECHNICAL DEPARTMENT. IT SEEMS MOST LIKELY THAT THE SHARP EDGES ON THE INNER METAL PLATE WAS A RESULT OF NON-CONFORM PART DELIVERED FROM THE SUPPLIER. THE EDGES OF THIS PART SHOULD BE BLUNTED AFTER LASER CUTTING. HOWEVER, THIS COMPONENT HAD SHARP EDGES AND NO SIGNS OF ANY PROCESSING ON THIS PART CAN BE SEEN. ARJO DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATION SINCE THE EDGE OF THE METAL PART WAS SHARP AND NOT DULLED. THE DEVICE WAS NOT USED FOR A PATIENT TREATMENT AT THE TIME OF THE EVENT. THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO SERIOUS INJURY REPORTED.

Description of Event or Problem

ARJO WAS NOTIFIED OF AN INCIDENT INVOLVING A SYSTEM 2000 BATHTUB. ACCORDING TO INFORMATION PROVIDED WHILE PERFORMING ANNUAL PREVENTIVE MAINTENANCE AT THE CUSTOMER'S SITE, AN ARJO SERVICE TECHNICIAN INJURED HIS FOREARM. HE TRIED TO REMOVE THE CARTRIDGE. THE TOP OF THE CARTRIDGE POPPED OUT AND, WHILE ATTEMPTING TO REMOVE IT, THE TECHNICIAN INJURED HIS FOREARM ON THE INNER METAL PLATE THAT GOES ALONG THE BATHTUB. THE INJURY REQUIRED A SUTURE ON THE FOREARM.

Additional Manufacturer Narrative

THE INVESTIGATION IS ONGOING AND FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.