BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMTOUCH

    MDR report key: 12258549 · Received August 2, 2021

    Report

    Report Number
    2936999-2021-00755
    Event Type
    Malfunction
    Date Received
    August 2, 2021
    Date of Event
    June 28, 2021
    Report Date
    October 19, 2021
    Manufacturer
    SANMINA SCI CORPORATION
    Product Code
    DWJ
    UDI-DI
    10884521141100
    PMA / PMN Number
    K123083
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE ANALYSIS FOUND THAT THE THERMOSTAT CABLE AND THE THERMISTOR CABLE WERE NOT CONNECTED TO THE POWER CIRCUIT BOARD. THE THERMOSTAT CABLE CONNECTOR WAS DAMAGED/WORN ON BOTH THE CABLE AND THE POWER CIRCUIT BOARD. THE ISSUE WAS RESOLVED BY REPLACING THE POWER CIRCUIT BOARD AND THERMOSTAT CABLE. IT WAS REPORTED THAT THE PRODUCT HAD AN ISSUE WITH THE ALARM SYSTEM AND THE UNIT WOULD NOT TURN ON. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE WAS TRACED TO A COMPONENT FAILURE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE UNIT SHUT DOWN AUTOMATICALLY WITHOUT ERROR MESSAGE AND NO ALARM SOUNDS. UNIT WAS POWER CYCLED. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE UNIT SHUT DOWN WITHOUT ERROR MESSAGE AND NO ALARM SOUNDS. UNIT WAS POWER CYCLED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159398 WARMTOUCH SYSTEM, THERMAL REGULATING DWJ SANMINA SCI CORPORATION 5016000 10884521141100

    Patients

    Seq Age Sex Outcome Treatment
    1