Additional Manufacturer Narrative · 1
A SVC REP VISITED THE HOSP AND EVALUATED THE DEVICE. THE COLUMN WAS INSTALLED IN A TRIAGE/EXAMINATION ROOM AND HOSP STAFF INDICATED THAT IT WAS NOT REGULARLY IN SVC. THE SVC REP FOUND THE COLUMN HAD BEEN FASTENED TO THE MOUNTING COLLAR WITH 4 HEX BOLTS. HOWEVER, THE COLLAR WAS MOUNTED TO THE ARM WITH 4 PHILLIPS-HEAD SCREWS. THE TECH REPORTED THE HEX-HEAD BOLTS THAT ATTACH THE COLUMN TO THE SUSPENSION APPEARED COMPLETELY UNDAMAGED. HOWEVER, 3 OF THE 4 PHILLIPS SCREWS HAD WORKED LOOSE AND THE HEAD OF THE 4TH SCREW WAS FOUND BROKEN OFF. THE 3 LOOSE SCREWS SHOWED NO SIGN OF DAMAGE. THE TECH ALSO REPORTED THAT BEFORE THEIR ARRIVAL, SOMEONE HAD UNSCREWED THE BACK PANEL FROM THE NEST AND IT WAS FOUND HANGING BY THE ATTACHED GAS HOSES. WHO DETACHED THE PANEL AND WHY IS UNK. THE HOSP IS THE PRIMARY MAINTENANCE PROVIDER FOR THE EQUIPMENT MGR. A SVC LOG WITH MAINTENANCE HISTORY WAS NOT MADE AVAILABLE TO THE MFR'S SVC REP SO THE DATE OF LAST SVC CANNOT BE ASCERTAINED. THE HOSP BIOMEDICAL STAFF REMOVED THE UNIT FROM THE TRIAGE ROOM IN 2008. ALL BUT ONE OF THE SCREWS WERE REPORTED TO BE SCRAPPED DURING THIS PROCESS. AT THIS TIME, THERE IS NOT ENOUGH INFO TO DEFINITIVELY ESTABLISH THE ROOT CAUSE OF THIS INCIDENT. 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.