UNKNOWN
Received May 17, 1993 · Event occurred Mar 29, 1993
Report 5177 · MDR key 5177
Device
Patient
91 YR
Narrative
Description of Event or Problem
RESIDENT WAS FOUND WITH HEAD STUCK IN RIGHT SIDE RAIL ON BED, HAD SCRAPPED AREA 1/2" ON FOREHEAD WITH READ AREA ON NECK. RESIDENT DEVELOPED 4 AND 1/2" BRUISE ON FORHEAD AROUND SCRAPED AREA. SIDE RAILS WERE COVERED WITH FOAM PADDING WITH SHEET WRAPPED AROUND THEM TO PREVENT FURTHER INJURYDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: UNKNOWN. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.