Description of Event or Problem · 1
PATIENT WAS IN BED, HUSBAND IN RECLINER BY BED, AND NURSE AT HEAD OF BED OBTAINING INFORMATION FROM THE PATIENT WHEN THE CHIK LIGHT FELL FROM THE CEILING TO A MIDWAY POSITION IN A SUDDEN MOTION WITHOUT ANY STIMULATION. FORTUNATELY NO ONE WAS INJURED. THE ACTUATOR WAS HANGING BY WIRES. THE METAL ATTACHMENT TO THE CEILING HAD RIPPED THE METAL. ENCLOSED IS A PICTURE FOR BETTER UNDERSTANDING. MIDMARK WAS NOTIFIED; THEY HAVE RETRIEVED THE ACTUATOR. THEY ALSO CHECKED ALL OUR SIMILAR LIGHTS IN L & D. WE WILL BE SUPPLIED WITH AN EXPLANATION AFTER EVALUATIONDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 3.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN, NONE OR UNKNOWN, UNANTICIPATED, OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.