BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GS 777 WALL TRANSFORMER US

    MDR report key: 12337844 · Received August 18, 2021

    Report

    Report Number
    1316463-2021-00029
    Event Type
    Malfunction
    Date Received
    August 18, 2021
    Date of Event
    July 19, 2021
    Report Date
    September 16, 2021
    Product Code
    HMF
    UDI-DI
    00732094136906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER ALLEGED THAT THE DEVICE HAD PHYSICAL DAMAGE AS IT STARTED A FIRE ON THE OUTLET. NO INJURY OR DELAY WAS REPORTED. HILLROM HAS RECEIVED THE DEVICE FROM THE CUSTOMER AND HAS CONCLUDED A ROOT CAUSE INVESTIGATION BY THE MANUFACTURING SITE. THE GS 777 WALL TRANSFORMER IS INTENDED TO PROVIDE POWER TO WELCH ALLYN 3.5V INSTRUMENTS. THE DEVICE POWERS TWO INSTRUMENT HANDLES, ONTO WHICH WELCH ALLYN 3.5V DIAGNOSTIC INSTRUMENT HEADS CAN BE ATTACHED. THESE DIAGNOSTIC INSTRUMENT HEADS INCLUDE THE WELCH ALLYN OTOSCOPE, OPTHALMOSCOPE AND EPISCOPE. THE WALL TRANSFORMER CAN BE USED ALONE, OR AS PART OF THE GS 777 INTEGRATED WALL SYSTEM (IWS), WHICH INCORPORATES OTHER WELCH ALLYN DEVICES, SUCH AS THE SURETEMP THERMOMETER, SPOT VITAL SIGNS MONITOR AND THE PROBP 3400 AND THE ANEROID BLOOD PRESSURE GAUGE. AFTER INITIAL REVIEW OF THE POWER SUPPLY IT IS EVIDENT THAT A SHORT OCCURRED AT THE AC POWER INPUT OF THE POWER SUPPLY. THE FIRE WAS CAUSED BY AN ELECTRICAL ARCING EVENT THAT OCCURRED BETWEEN THE CONDUCTIVE TABS INSIDE THE ADAPTER PLUG SUBASSEMBLY. THIS ARCING EVENT WAS DUE TO LIQUID IN THE SUBASSEMBLY ELECTRICAL CONNECTING THE TWO TABS. THE LIQUID MOST LIKELY ENTERED THE SUBASSEMBLY AS A RESULT OF CLEANING THE DEVICE. WELCH ALLYN, INC. (A HILL-ROM COMPANY) ISSUED A FIELD SAFETY NOTICE WITH THE REFERENCE MOD1329 IN 2021 TO NOTIFY USERS OF THE POTENTIAL RISK ASSOCIATED WITH INADVERTENT FLUID INGRESS SECONDARY TO THE CLEANING OF POWER SUPPLIES USED WITH WELCHALLYN GS777 WALL TRANSFORMER, AND TO PROVIDE INSTRUCTIONS FOR APPROPRIATELY CLEANING THE POWER SUPPLY. THE GS777 WALL TRANSFORMER WAS PLACED ON THE MARKET IN 2012 AND IS STILL BEING SOLD. THERE IS A RISK OF AN INTERNAL ELECTRICAL SHORT AND POSSIBLE ELECTRICAL SHOCK OCCURRING IF CLEANING FLUID INGRESSES INTO THE POWER SUPPLY, AND THE POWER SUPPLY IS PLUGGED INTO THE ELECTRICAL OUTLET BEFORE THE CLEANING FLUID HAS COMPLETELY DRIED. AS A RESULT OF MOD1329, HILLROM UPDATED THE GS777 INSTRUCTIONS FOR USE (IFU) TO INCLUDE THE REVISED CLEANING RECOMMENDATIONS. NO INJURY REPORTED, BUT BASED ON THE RECURRENCE HILLROM CONSIDERS THIS EVENT REPORTABLE. THE TECHNICIAN REPLACED THE POWER CORD TO RESOLVE THE ISSUE, AND THE DEVICE IS WORKING AS INTENDED. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 0

    HILLROM RECEIVED A REPORT FROM A CUSTOMER ALLEGING DEVICE HAD PHYSICAL DAMAGE AS IT STARTED A FIRE ON THE OUTLET. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ALLEGED THAT THE DEVICE HAD PHYSICAL DAMAGE AS IT STARTED A FIRE ON THE OUTLET. NO INJURY OR DELAY WAS REPORTED. HILLROM HAS RECEIVED THE DEVICE FROM THE CUSTOMER TO ALLOW THE INVESTIGATION BY THE MANUFACTURING SITE. NO FURTHER INFORMATION IS AVAILABLE ON THE DEVICE. THE ROOT CAUSE ANALYSIS IS ONGOING AND THE DEVICE IS LOCATED AT THE HILLROM FACILITY FOR INVESTIGATION. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILLROM RECEIVED A REPORT FROM A CUSTOMER ALLEGING DEVICE HAD PHYSICAL DAMAGE AS IT STARTED A FIRE ON THE OUTLET. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236439 GS 777 WALL TRANSFORMER US STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC HMF 77710 00732094136906

    Patients

    Seq Age Sex Outcome Treatment
    1