Description of Event or Problem · 0
CASE (B)(4); REPORTED ON 9/27/2023 BY CONTACT (B)(6) HOSPITAL. CASE DESCRIPTION: DOES NOT CHARGE ON KNOWN WORKING CC500; WHEN AV500 IS PLACED IN CC500 THE LED TURNS ON, BUT LCD STAYS OFF. AV500 LEFT TO CHARGE OVERNIGHT AND DID NOT GAIN BATTERY LIFE. BIOMED SAID HE NOTICED A BURNED PLASTIC SMELL; UNIT IS NOT HOT TO TOUCH, AND NO ONE WAS HARMED. CASE (B)(6); REPORTED ON 10/16/2023 BY CONTACT (B)(6) HOSPITAL. CASE DESCRIPTION: HAS BURNED CHARGING PINS, SMELLS LIKE BURNED PLASTIC, NO ONE WAS HARMED. BIOMED TOSSED CRADLES [NOTE THE PLURAL] AWAY THOSE WERE ALSO DAMAGED AND MELTED ALSO TOSSED POWER SUPPLIES. ROOT CAUSE OF THE PROBLEM (IF KNOWN): UNKNOWN AT THIS TIME. A CAPA, 23-000040 WAS OPENED IN THE ACCUVEIN QUALITY MANAGEMENT SYSTEM ON 2023.11.02. IT IS EXPECTED THE PROBABLE CAUSE AND PROXIMAL CAUSE IS HUMAN PERFORMANCE ERROR, AS THE ACCUVEIN-PROVIDED POWER SUPPLIES (PS310, PS410, AND PS510) CANNOT, BY DESIGN, SERVE AS THE ROOT CAUSE OF THESE MALFUNCTIONS. NOTE: THE COMPLAINANT NEVER MENTIONED THE MODEL NUMBERS OF THE POWER SUPPLIES (WHICH SHOULD HAVE BEEN PS510), YET THEY WERE COGNIZANT ENOUGH TO LIST THE MODEL NUMBERS OF THE CHARGING CRADLES; I.E., CC500. FACTORS THAT MAY CONTRIBUTE TO PRODUCT RISK (I.E. DEVICE DESIGN, MANUFACTURING PROBLEMS OR USER ERROR): HUMAN PERFORMANCE ERROR; ACCUVEIN SUSPECTS THE PROBABLE CAUSE IS THE USE OF UNAPPROVED EXTERNAL POWER SUPPLIES, THE RESULT IS AN INCORRECT VOLTAGE WAS SUPPLIED TO THE CC500 CHARGING CRADLE. REFERENCE REPORT: MW5148284.