Description of Event or Problem · 1
PATIENT TRIED TO GET OUT OF BED, WAS RESTRAINED BY POSEY AND BECAME ENTANGLED IN POSEY AND BED SIDERAIL. BED SIDERAIL AND POSEY BOTH RESTRICTED PATIENT'S ABILITY TO BREATH; THUS, PATIENT ARRESTED, AND SUBSEQUENTLY EXPIRED TWO WEEKS LATER. AS A RESULT OF OUR EVALUATION, CONSIDERATION WILL BE GIVEN TO ADDITIONAL MONITORING OF RESTRAINED PATIENTS.RELEVANT DEVICE: HILL-ROM CO., INC. - CENTRA RETRACTABLE BEDEVICE 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: 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, OTHER, OTHER. RESULTS OF EVALUATION: OTHER. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE DISCARDED, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.