BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL GRADE UPS WITH ISOLATION (NORTH AMERICA 5-15R HG PLUG)

    MDR report key: 19276866 · Received May 9, 2024

    Report

    Report Number
    9612330-2024-00023
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    May 6, 2024
    Report Date
    August 2, 2024
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF NATUS COMPLAINT#(B)(4). THE CUSTOMER REPORTED THE ISSUE WHICH UPS WAS PLUGGED IN AND INSTANTLY HAD A SPARK, SMOKE AND FIRE AS WITNESSED BY EEG TECH(S). THE TECHNICAL SUPPORT (TS) ADVISED THE CUSTOMER TO KEEP IT UNPLUGGED, AND KEEP UPS DEVICE AS OUR ENGINEERING TEAM MAY WANT ITEM BACK TO INVESTIGATE. THE CUSTOMER SAID THEY WERE DOING THEIR OWN INTERNAL INVESTIGATION, NOT PLUGGING ANYTHING ELSE INTO THE OUTLET, AND WERE HAVING AN ELECTRICIAN INSPECT OUTLET TO MAKE SURE IT WAS GOOD. THE CUSTOMER SAID THE SYSTEM WORKED FINE IN ANOTHER AREA AND THIS ONLY HAPPENED ONCE THEY MOVED IT TO THIS LOCATION AND PLUGGED IN. NO PATIENT OR USER HARM. TECHNICAL SUPPORT HAVE SENT A QUESTIONNAIRE TO THE CUSTOMER, AND ASKED THAT THE AFFECTED PART BE RETURNED FOR EVALUATION. UDI NOT APPLICABLE. NO RELATED CAPAS. RISK REVIEW: PER (B)(4) REV 69 XLTEK EEG/PSG RISK ANALYSIS SPREADSHEET, HAZARD ID 2.1 CAUSE: FAILURE OF AMPLIFIER POWER SUPPLY/ TRANSFORMER. EFFECT (HARM): RANGE FROM CLINICALLY INSIGNIFICANT TO MAJOR INJURY FROM BURNS. RBA RATING: MEDIUM THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018, HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). INSTALL DATE OF AFFECTED DEVICE: 16-JUN-2022. NATUS SENT THE REPLACEMENT MEDICAL GRADE UPS WITH ISOLATION (NORTH AMERICA 5-15R HG PLUG) (P/N UPS-NA) TO THE CUSTOMER AS THE RESOLUTION. TPI-4215 WAS CREATED. ENGINEER PERFORMED THE INITIAL EVALUATION AND NOTED THE FOLLOWING: CHECKED THE UNIT IT TURNS ON NORMALLY. TRIED AT TWO DIFFERENT OUTLETS. NO FIRE/SMOKE/SPARK. CONNECTED TO THE QUANTUM BASE NO ISSUES WORKS NORMALLY. (B)(6) 2024: THE CUSTOMER CALLED BACK TO REQUEST THE UPDATES FROM ENGINEERING. THE CUSTOMER ADVISED THE ENGINEER TO TAKE THE COVER OFF THE BATTERY PACK AND LOOK AT THE INSIDE OF IT, AND SEE THAT THE INSIDE OF THE BATTERY PACK CAUGHT ON FIRE. THE BATTERY PACK CAUGHT ON FIRE FROM THE INSIDE. 5-JUN-2024: ENGINEERING OPENED THE UPS UNIT CASE AND FOUND BURN ON THE METAL PLATES ON THE ACTUAL MOTHERBOARD. COUPLE OF TRANSISTORS GOT BURN. (BUT WORKED NORMALLY WHEN TURNED ON). 21-JUN-2024, 1-JUL-2024: ENGINEERING FOLLOWED UP WITH POWERVAR. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT# (B)(4). ON 11 JULY 2024 - POWERVAR CARRIED OUT THEIR INVESTIGATION AND VERIFIED THE ROOT CAUSE AS - MAIN PCB BOARD FAILED DUE TO COMPONENT FAILURE ON THE MAIN BOARD (FET FAILURE). THEY WILL MONITOR THE MAIN PCB, A26-00384, FOR OTHER RETURNS FOR FET FAILURES TO DETERMINE IF LARGER ISSUE EXISTS THROUGH THE SERVICE RETURN PROCESS.

    Description of Event or Problem · 0

    PART UPS-NA MEDICAL GRADE UPS WITH ISOLATION (NORTH AMERICA 5-15R HG PLUG) - THE CUSTOMER REPORTED THE ISSUE WHICH UPS WAS PLUGGED IN AND INSTANTLY HAD A SPARK, SMOKE AND A FIRE EVENT. NO INJURIES.

    Description of Event or Problem · 0

    PART UPS-NA MEDICAL GRADE UPS WITH ISOLATION (NORTH AMERICA 5-15R HG PLUG) - THE CUSTOMER REPORTED THE ISSUE WHICH UPS WAS PLUGGED IN AND INSTANTLY HAD A SPARK, SMOKE AND A FIRE EVENT. NO INJURIES.

    Description of Event or Problem · 0

    PART UPS-NA MEDICAL GRADE UPS WITH ISOLATION (NORTH AMERICA 5-15R HG PLUG) - THE CUSTOMER REPORTED THE ISSUE WHICH UPS WAS PLUGGED IN AND INSTANTLY HAD A SPARK, SMOKE AND A FIRE EVENT. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469770 MEDICAL GRADE UPS WITH ISOLATION (NORTH AMERICA 5-15R HG PLUG) MEDICAL GRADE UPS WITH ISOLATION (NORTH AMERICA 5-15R HG PLUG) GWQ NATUS MEDICAL INCORPORATED UPS-NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown