FLOWTRON ACS900

Description of Event or Problem

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).