[19774636]
A 71 year old female patient with diagnosis of fractured humerous had surgery on 11/3 for open reduction. She was odered to have this device one day post op. It was started by a pt therapist who stated it was on correctly & working well. However the patient was verbaliziong fear of being electrocuted and did not want it on. She was educated & seemed to relax & accept it. Later in the pm she became very anxious of the device. The nurse turned it off but did not remove the device. It appears the patient removed some of the straps although she denies doing so. The patient arm was moved incorrectly causing it to dislocate. A 2nd surgery was required. It appears that the machine was functioning correctly. The issue may be that the device should not have been placed on a person who is fearful & may not cooperate. In service education will be given to the physical therapy staff & nursing whena device like this is ordered, to evaluate if a patient is comfortable & able to cooperatedevice 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: visual examination. Results of evaluation: none or unknown. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: user education provided. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5