[185052208]
My father is in (b)(6) regional hosp for treatment of a stroke. A flowtron acs900 dvt compression pump is being used on him. On (b)(6) 2020 i noticed the display had a symbol with an exclamation mark and another symbol displayed. Due to the shortened visiting time, i was not able to investigate what it was. On the morning of (b)(6) 2020 it was discovered that my father was not responsive, a stroke code was called. He was sent for ct and mri testing which showed another stroke. When i visited him later in the day, i investigated the error on the pump by downloading the manual. I noticed that there was also a recall for the acs900, during my search for a manual. The troubleshooting section indicated that the display was indicating a malfunction / leak in port 1 of the pump. The pressure on port 1 would quickly raise to 70 mmhg and fall to zero, meaning there was no compression of the limb attached to that port. The pressure on port 2 ramped up to 40 mmhg and held for a few seconds, then released, this seemed to be normal operation. I have video and pictures of this operation, the asset tags and serial number of the machine. I contacted arjo to verify if the recall work was performed on the pump, after providing the serial number, i was told it was not corrected. I believe my father's stroke in the hosp was a result of the pump failure, only one of his legs were being compressed to prevent a dvt and stroke. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5