Description of Event or Problem · 1
10/5/98. HOSP HAS BEEN OFFERED THE HUNTLEIGH FLOWTRON MODEL #AC500 INTERMITTENT PNEUMATIC COMPRESSION PUMP TO BE USED FOR THE PREVENTION OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM IN PT POPULATION. AFTER HAVING HOSP BIOMED PERSONNEL EXAMINE THE AC500 PUMP FOR THE REQUIRED UL544 MEDICAL AND DENTAL EQUIPMENT REGULATION COMPLIANCE, BIOMED HAS DETERMINED THE PRODUCT DOES NOT CURRENTLY MEET THREE UL544 STANDARDS: 1) UL544 24.4, 24.5 - THE AC500 PUMP IS NOT PROPERLY GROUNDED BECAUSE ASSEMBLY SCREWS WERE USED TO GROUND THE DEVICE. THIS PRESENTS A PROBLEM OF A PPOSSIBLE 110 VOLT SHOCK TO HOSP PERSONNEL OR PTS. 2) UL544 62.1, 67.1 (ATTACHED) - THE AC500 PUMP DOES NOT HAVE THE PROPER LABEL ON THE ELECTRICAL CORD AND IS MISSING THE "DANGER" LABEL REQUIRED FOR ANESTHESIA CAUTION. HUNTLEIGH'S NEW MODEL AC550 DOES NOT APPEAR TO HAVE THE SHORTCOMINGS IN UL REQUIREMENTS AS DOES THEIR AC500 MODEL. HOWEVER, RPTR IS TOLD THERE ARE SEVERAL THOUSAND OF AC500 PUMPS IN HOSPITALS TODAY. ONE REF GIVEN WAS A HOSP WHERE SOME TWO HUNDRED OF THESE AC500 PUMPS ARE IN OPERATION. THE POSSIBLE SHOCK TO INDIVIDUALS DUE TO THIS IMPROPER GROUNDING AND NOT MEETING THE BASIC UL544 REQUIREMENT IS THE CRITICAL ISSUE. AS A HEALTH CARE PROFESSIONAL BELIEVES HUNTLEIGH SHOULD HAVE TO REMOVE ANY AND ALL OF THE MANY AC500'S IN EXISTENCE AND, AT A MINIMUM, BRING THESE DEVICES TO MEET CURRENT UL544 STANDARDS OR REPLACE THEM WITH A MODEL WHICH DOES MEET THE UL STANDARD TO PREVENT ANY HARMFUL SITUATION FROM EVER HAPPENING.