Additional Manufacturer Narrative · 1
THE FIELD INVESTIGATION FOUND THE SCREW SECURING THE SAFETY COLLAR, THE SAFETY COLLAR AND RETAINING SEGMENT WERE MISSING. MAQUET TECHNICAL PERSONNEL WERE UNABLE TO LOCATE THE MISSING COMPONENTS WHILE SERVICING THE LIGHT. THESE 3 SAFETY COMPONENTS ARE CRITICAL TO SECURING THE LIGHT HEAD TO THE SPRING ARM. MAQUET MAINTENANCE PROGRAM RECOMMENDATIONS INCLUDE REGULAR INSPECTION OF THESE SAFETY ELEMENTS. MAQUET IS NOT THE PRIMARY SERVICE PROVIDER FOR THIS HOSP. THE CUSTOMER CHOSE AN ALTERNATE SERVICE SUPPLIER TO PERFORM SURGICAL LIGHTS MAINTENANCE. THE MOST PROBABLE ROOT CAUSE IS A LACK OF MAINTENANCE ON THIS SURGICAL LIGHT. MAQUET TECHNICAL STAFF REPAIRED THE DAMAGED LIGHT AND INVESTIGATED OTHER SURGICAL LIGHTS IN THE FACILITY. AFTER THE INVESTIGATION, MAQUET COMMUNICATED TO THE CUSTOMER THAT MAINTENANCE PROGRAM RECOMMENDATIONS HAVE NOT BEEN FOLLOWED TO MFR'S SPECS. A RECOMMENDATION HAS BEEN OFFERED TO THE CUSTOMER TO RETORE ALL THE SURGICAL LIGHTS TO THEIR PROPER CONDITION. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.