[17435902]
Aalert system to alert nurses and staff/resident is entering an unrestricted area. Alert alarm did not sound. At lunch time 12:00, resident was eating, all staff were in dining room feeding other 42 residents when resident involved left his table when he was finished eating. The resident is sitting in a wheelchair, went to the door with the code alert system attached installed, opened the door and went through, at which time the code alert system failed because the resident involved was wearing a bracelet on the ankle which activates the alert system. The alert szystem should have alarmed the staff. The door is not vivisle from the staff at time of feeding other residents. Resident fell down stairs behind unauthorized area pronounced dead at the sceneinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. 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. Invalid data - whether device used as labeled/intended. Device was evaluated after the event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5