inforMED
ILO

AQUA RELEASE SYSTEM

Received May 26, 2009

Report MW5011216 · MDR key 1393327

Device

Generic name

Water Circulating Pump

Model number

ARS-2000 D

Product problems

  • Design/structure problem
  • Incomplete or Missing Packaging
  • Labeling, missing

Patient

*

  • No Patient Involvement

Narrative

Description of Event or Problem

REPORTER CONCERNED ABOUT POSSIBLE SAFETY HAZARDS DUE TO PROBE HANGING OUT OF DEVICE. REPORTER CONCERNED THAT SOMEONE COULD BE BURNED FROM THIS DEVICE. ALSO CONCERNS ABOUT ELECTRICAL SAFETY BECAUSE DEVICE HAS 120V AC, AND 110 DC OUT. ALSO CONCERNS REGARDING DEVICE ELECTRICAL PLUG. REPORTER USED TO SEEING 3 PRONG PLUG ON MEDICAL DEVICES BUT THIS DEVICE ONLY HAS 2 PRONG PLUG. DEVICE HAS 4" X 1/8" HEATING ELEMENT THAT COULD POSSIBLY BURN PATIENT. DEVICE IS ALSO MISLABELED, NO SAFETY STANDARDS ON DEVICE OR PACKAGING. NO INFORMATION REGARDING LOT#, CAT #, NO MANUFACTURER TELEPHONE #.