BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRO 6000 W/SMALL CRADLE

    MDR report key: 11739895 · Received April 28, 2021

    Report

    Report Number
    1316463-2021-00002
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 20, 2021
    Report Date
    April 28, 2021
    Manufacturer
    WELCH ALLYN INC.
    Product Code
    FLL
    UDI-DI
    00732094309003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEY OBTAINED HOT PROBE TIP ON 7 DEVICES FROM JANUARY 2020 TO DATE. ALL 7 DEVICES WERE INSPECTED BY THE HILLROM SERVICE CENTRE. HILLROM WAS NOT ABLE TO REPRODUCE THE MALFUNCTION ON THE FOLLOWING SERIAL NUMBERS: (B)(4). THE SN (B)(4) WAS RECEIVED AT HILLROM SERVICE CENTRE ON 12APR2021 AND PRELIMINARILY INSPECTED BY THE SERVICE CENTRE. THE FOLLOWING WAS IDENTIFIED: DOES THE DEVICE TURN ON AND OFF? NORMALLY. ARE THERE ANY SIGNS OF CONTAMINATION, SUCH AS FLUID INGRESS? YES, ON THE DOCK CONNECTOR. ARE THERE ANY SIGNS OF PHYSICAL DAMAGE? YES, LIQUID INGRESS. CAN THE HOT PROBE TIP MALFUNCTION BE REPRODUCED? YES. THE BRAUN THERMOSCAN® PRO 6000 EAR THERMOMETER IS INDICATED FOR THE INTERMITTENT MEASUREMENT OF HUMAN BODY TEMPERATURE. AS PER DESIGN THE HEATING ELEMENT IS PROGRAMMED TO SHUT OFF AT TARGET OF 37C (98.6F) DURING A TEMPERATURE MEASUREMENT. DUE TO THIS BUILT-IN SAFETY CUT OFF, IT IS UNLIKELY THAT A SERIOUS INJURY WOULD OCCUR DUE TO A HOT PROBE TIP. ADDITIONALLY, THE DEVICE HAS A SAFETY CUT OFF AT 45C (113F) FOR THE TP HEATING ELEMENT, WHICH IS IN LINE WITH THE GENERAL SAFETY STANDARD 60601-1 CLAUSE 11 THAT SETS THE ALLOWABLE MAXIMUM TEMPERATURE FOR SKIN CONTACT. IEC 60601-1-11:2015 APPLIES TO THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS FOR USE IN THE HOME HEALTHCARE ENVIRONMENT. IN THE SIX (6) INITIAL SERIAL NUMBERS REPORTED ABOVE, THERE WAS NO SERIOUS INCIDENT REPORTED AND THE MALFUNCTION REPORTED BY THE CUSTOMER COULD NOT BE REPLICATED BY HILLROM¿S SERVICE CENTRE. THEREFORE, HILLROM DOES NOT CONSIDER THESE COMPLAINTS REPORTABLE. FOR REPORTED MALFUNCTION RELATED TO SN (B)(4) , AFTER REPLICATING STATED MALFUNCTION AT THE SERVICE CENTRE, THE DEVICE WAS SENT TO THE MANUFACTURING SITE. THE HILLROM MANUFACTURING SITE WAS NOT ABLE TO REPRODUCE THE MALFUNCTION ON THE DEVICE. HOWEVER, THE HILLROM MANUFACTURING SITE HAS RECENTLY BEEN ABLE TO REPRODUCE THE HOT PROBE TIP MALFUNCTION, WITH NEW DEVICES, WHEN THE DEVICES ARE SUBJECTED TO VARIOUS CLEANERS IN AN AGGRESSIVE CLEANING SIMULATION. IT IS BELIEVED THAT, DUE TO SERVICE CENTRE BEING ABLE TO REPRODUCE THE MALFUNCTION THAT, REPLICATION OF THE MALFUNCTION WITH THE SN (B)(4) AT THE MANUFACTURING SITE HAS NOT BEEN POSSIBLE AS ANY FLUID THAT MAY HAVE INGRESSED HAD LIKELY EVAPORATED, THEREFORE NOT SHOWING THE HOT TIP MALFUNCTION. BASED ON HILLROM¿S ABILITY TO REPLICATE THE MALFUNCTION OF A HOT TIP ON NEW DEVICES THAT CAN POTENTIALLY GO ABOVE THE BUILT IN RISK MITIGATIONS OF A SAFETY CUT OFF THAT COULD POTENTIALLY CAUSE A MORE SERIOUS INJURY WE HAVE DEEMED THIS COMPLAINT TO BE REPORTABLE. FURTHERMORE, HILLROM IS ACTIVELY WORKING WITH THE CUSTOMER TO CONFIRM THAT THE DEVICES MENTIONED IN THE USER REPORT TO MHRA ARE THE ONES IDENTIFIED IN OUR COMPLAINT HANDLING SYSTEM. IF THE CUSTOMER IDENTIFIES ANY ADDITIONAL SERIAL NUMBERS, INDIVIDUAL COMPLAINTS WILL BE CREATED FOR THESE AND FURTHER INVESTIGATED.

    Description of Event or Problem · 1

    ON (B)(6) 2021, HILLROM RECEIVED A USER REPORT FROM MHRA IN WHICH THE CUSTOMER REPORTED THE FOLLOWING: TIP PREHEATER WILL HEAT THE TIP TO IN EXCESS OF 53 DEGREES CENTIGRADE IN A FAULT MODE WITH POTENTIAL FOR SERIOUS BURNS TO PATIENTS, PARTICULAR THOSE UNCONSCIOUS OR UNABLE TO RESPOND TO PAIN SIGNALS. ONE PROVEN CASE (REPLICATED ON WORKBENCH) ON 20TH MARCH 2020 HAS NOW BEEN FOLLOWED BY FOUR OTHER CASES OVER THE LAST 12 MONTHS ON DIFFERENT DEVICES OF THE SAME MODEL; A TOTAL OF AT LEAST 5 CASES IN 12 MONTHS FOR OUR TRUST. EACH INSTANCE HAS THANKFULLY BEEN INTERVENED BY THE CLINICAL STAFF NOTICING THE TIP WAS BURNING HOT, SOMETIMES WITH AN ODOR, SHORTLY BEFORE APPLICATION TO PATIENT'S EAR. SEEMS RELATED TO VERY HIGH FAILURE RATE OF AROUND 20% IN FIRST YEAR WITH THIS DEVICE BY SURVIVAL ANALYSIS. HILLROM PULLED A REPORT FROM JANUARY 2020 TO DATE ON COMPLAINTS RECEIVED FOR HOT PROBE TIP FOR BRAUN PRO6000 THERMOMETERS FOR THIS CUSTOMER. HILLROM IDENTIFIED THE CUSTOMER REPORTED 7 DEVICES WITH REPORT OF HOT PROBE TIP DURING THIS TIME FRAME. THE LIST OF COMPLAINTS ARE AS FOLLOWS: ON 24JUL2020 THE CUSTOMER REPORTED THAT THEY HAD ONE BRAUN PRO6000 WITH AN OVERHEATING PROBE TIP. THE DEVICE (SN (B)(4)) WAS RETURNED TO HILLROM'S SERVICE CENTRE AND INSPECTED. THE MALFUNCTION COULD NOT BE REPLICATED AND HILLROM DEEMED THE COMPLAINT NON REPORTABLE. ON 08JAN2021 THE CUSTOMER REPORTED THAT THEY HAD 4 BRAUN PRO6000 WITH AN OVERHEATING PROBE TIP. THE 4 DEVICES (SNS (B)(4) ) WERE RETURNED TO HILLROM'S SERVICE CENTRE AND INSPECTED. THE MALFUNCTION COULD NOT BE REPLICATED AND HILLROM DEEMED THE COMPLAINTS NON REPORTABLE. ON 25JAN2021 THE CUSTOMER REPORTED THAT THEY HAD ONE BRAUN PRO6000 WITH AN OVERHEATING PROBE TIP (SN (B)(4) ). THE DEVICE WAS RETURNED TO HILLROM SERVICE CENTRE AND INSPECTED. THE MALFUNCTION COULD NOT BE REPLICATED. HILLROM DEEMED THE COMPLAINT NON REPORTABLE ON 15FEB2021. ON 08FEB2021 THE CUSTOMER REPORTED THAT THEY HAD ONE BRAUN PRO6000 WITH AN OVERHEATING PROBE TIP (SN (B)(4) ). AS OF 04MAR2021 THE DEVICE HAD NOT BEEN RETURNED AND HILLROM DEEMED THE COMPLAINT NON REPORTABLE ON 04MAR2021, BASED ON THE INFORMATION AVAILABLE AT THAT TIME. HILLROM¿S SERVICE CENTRE RECEIVED THE DEVICE ON 12APR2021 AND WAS ABLE TO REPRODUCE THE MALFUNCTION OF HOT PROBE TIP. THE COMPLAINT WAS REOPENED SO THAT REPORTABILITY COULD BE REASSESSED BASED ON NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636627 PRO 6000 W/SMALL CRADLE THERMOMETER, ELECTRONIC, CLINICAL FLL WELCH ALLYN INC. 06000-200 00732094309003

    Patients

    Seq Age Sex Outcome Treatment
    1