BONE DENSITOMETER

Description of Event or Problem

AS REPORTED BY THE FACILITY: PATIENT SAT ON A BONE DENSITY TABLE. RIVETS ON THE PLEXIGLASS FRAME BROKE, PLEXIGLASS FELL INTO TABLE LEAVING A HOLE UNDER PT AS SHE LAY SUPINE ON THE TABLE.

Additional Manufacturer Narrative

ON 09/20/06 THE HOSP REP CALLED HOLOGIC CUSTOMER SERIVCE, REPORTING THAT THE LISTED DEVICE MALFUNCTIONED AND REQUESTED INFO CONCERNING THE WEIGHT LIMIT ON THE TABLE. HOLOGIC PROVIDED THE WEIGHT LIMIT (300 IBS) AND DISPATCHED FIELD ENGINEERS WHO CONTACTED THE HOSP TO SCHEDULE A VISIT. AT THAT POINT THE HOSP REP DECLINED SERVICE AND INDICATED THAT THE DEVICE HAS BEEN REMOVED FROM USE. THE REP ALSO PROVIDED INFO THAT INDICATED THAT THE DEVICE WAS REPAIRED IN THE PAST NOT IN ACCORDANCE WITH THE MFR SPECIFICATION. THE REPAIR INVOLVED THE USE OF UNAUTHORIZED HARDWARE TO REPAIR THE DEVICE AT SOME POINT IN THE PAST. THE REPAIR WAS DIRECTLY IN THE AREA THAT WAS INVOLVED IN THE INCIDENT DESCRIBED IN THIS REPORT. ANY PREVIOUS PROBLEMS WITH THE DEVICE WERE NOT REPORTED TO HOLOGIC . HOLOGIC DID NOT SERVICE THIS EQUIPMENT DURING THE 15 YEARS THIS DEVICE WAS IN USE. HOLOGIC CONCLUDED, THAT THE FAILURE OCCURRED DUE TO THE USE OF THE UNAUTHORIZED AND UNVERIFIED HARDWARE (RIVETS) THAT WAS USED TO SUPPORT THE PLEXIGLASS SECTION OF THE TABLE.