inforMED
MalfunctionIME

POLAR CARE CUBE

Received Mar 12, 2013 · Event occurred Feb 17, 2013

Report 3008259 · MDR key 3008259

Device

Generic name

Pack, Hot Or Cold, Water Circulating

Manufacturer

Breg, Inc

Model number

*

Catalog number

10701

Lot number

*

Product problems

  • Device Operates Differently Than Expected

Patient

63 YR

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

POST-OP PATIENT'S POLAR CARE PAD WAS NOT BECOMING COLD. ALL CORDS CHECKED, NO OBVIOUS ISSUE NOTED. POLAR CARE UNIT REMOVED FROM PATIENT'S ROOM AND NEW POLAR CARE ORDERED.======================MANUFACTURER RESPONSE FOR POLAR CARE CUBE, POLAR CARE (PER SITE REPORTER).======================YES, THEY WERE VERY HELPFUL IN GIVING MANUFACTURER TIPS AND SUGGESTIONS FOR BEST PRACTICE: 1. UNIT WORKS BEST WHEN AT SAME LEVEL AS PATIENT (POLAR CARE UNIT PLACED ON BED, BEDSIDE TABLE, OR CHAIR) SO THE MACHINE WILL NOT HAVE TO WORK AS HARD TO BRING WATER INTO THE PAD.2. THE PAD SHOULD FIRST BE LAID FLAT AND TURNED ON.3. ONCE THE PAD IS COOL IT CAN BE APPLIED TO PATIENT.MANY OF THE POLAR CARE UNITS IN THE ORTHO UNIT ARE KEPT ON THE FLOOR SO WE ARE IN THE PROCESS OF SPEAKING TO THE VENDOR TO SEE IF THEY CAN COME AND RE-EDUCATE THE STAFF. WE ARE ALSO SPEAKING TO PACU AND OR STAFF BECAUSE THEY ARE THE ONES WHO USUALLY FIRST APPLY THE DEVICE WHEN THE PATIENT IS POST SURGERY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE?COOLING UNIT TO DECREASE SWELLING AND PAIN POST-OPERATIVELY.