IMAGE MANAGEMENT SYSTEM 660HD-E

Additional Manufacturer Narrative

H10 H3,H6: THE REPORTED DEVICE, USED IN TREATMENT, WAS RETURNED TO THE DESIGNATED COMPLAINT STATION FOR INDEPENDENT EVALUATION. THERE WAS A RELATIONSHIP FOUND BETWEEN THE RETURNED DEVICE AND THE REPORTED INCIDENT. A VISUAL INSPECTION WAS PERFORMED AND NO DEFICIENCIES WERE OBSERVED. A FUNCTIONAL EVALUATION REVEALED THAT THE PIP FUNCTION WAS NOT WORKING CORRECTLY. THE COMPLAINT WAS VERIFIED AND THE ROOT CAUSE WAS ASSOCIATED WITH DEVICE DESIGN. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION OR WOULD NOT BE ABLE TO PERFORM AS INTENDED. A REVIEW OF THIS COMPLAINT CASE REVEALED THERE WERE NO PATIENT INJURIES REPORTED AND NO APPARENT PATIENT IMPACT BASED ON THE DETAILS PROVIDED. THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED.

Description of Event or Problem

IT WAS REPORTED THAT THE DISPLAY SIGNAL WAS NOT STABLE DURING OPERATION. THERE WAS A DELAY GREATER THAN 30 MINUTES AND THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO INJURY OR COMPLICATIONS TO THE USER OR PATIENT WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.