WRIST RESTRAINT
Received Jan 1, 1993 · Event occurred Jun 27, 1992
Report 3640 · MDR key 3640
Device
Patient
38 YR
Narrative
Description of Event or Problem
PATIENT WAS FOUND MOTIONLESS ON THE ASPHALT GROUNDS OF THE HOSPITAL COURTYARD. PATIENT RESUSCITATED UNSUCCESSFULLY IN ER. PATIENT'S BED STILL WITH 4 SIDERAILS UP, UPPER LIMB, LOWER LIMB RESTRAINTS ATTACHED TO BE, LEFT LOWER LIMB RESTRAINT BROKEN, NO WITHNESSES TO ACTUALFALLDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.