BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINTLER PATIENT WARMING SYSTEM

    MDR report key: 7476587 · Received May 1, 2018

    Report

    Report Number
    3009976772-2018-00001
    Event Type
    Malfunction
    Date Received
    May 1, 2018
    Date of Event
    March 26, 2018
    Report Date
    April 11, 2018
    Manufacturer
    PINTLER MEDICAL, LLC
    Product Code
    DWJ
    PMA / PMN Number
    K113705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE PINTLER PATIENT WARMING SYSTEM: PAD - POSITIONED ON THE OPERATING ROOM TABLE, WAS NOTED BY STAFF PRESENT TO BE INCONSISTENTLY WARMING. ONE EDGE OF THE PAD FELT VERY WARM- THE REST OF THE PAD DID NOT FEEL WARM TO THE TOUCH. THE PINTLER PATIENT WARMING CONTROL UNIT DID NOT REGISTER ANY ALARMS. THERE WAS NO PATIENT INVOLVMENT. THE SYSTEM WAS REMOVED FROM SERVICE, TESTING WAS CONDUCTED BY FACILITY CLINICAL ENGINEERING. THE CLINICAL ENGINEERING STAFF MEASURED THE SURFACE TEMPERATURE OF THE EDGE OF THE PAD- WHERE THE PAD HAD FELT HOT. THEY REPORTED THIS ONE LATERAL EDGE WAS REGISTERING A SURFACE TEMP OF 100C . NO IRREGULAR TEMPERATURE WAS REGISTERED ANYWHERE ELSE ON THE PAD. PINTLER MEDICAL REPRESENTATIVE ARRIVED ON SITE 4/2/2018 TO WORK WITH THE ASSEMBLED FACILITY TEAM TO INVESTIGATE THE REPORT. FOR COMPARISON, A SECOND PINTLER WARMING SYSTEM, WAS TESTED TO CONFIRM OPERATION WAS WITHIN DEVICE SPECIFICATIONS. IT WAS CONFIRMED THAT ALL OPERATIONS WERE NORMAL. THE PAD WAS OPENED TO REVIEW THE WARMING SYSTEM ASSEMBLY/FUNCTION WITH FACILITY ENGINEERING REPRESENTATIVES. ALL TEMP SENSORS, WIRE HARNESSES, WERE IN PLACE AND THE PAD FUNCTIONED TO WARMING SPECIFICATION. THE FOAM WAS IN GOOD SHAPE, WITH NO INDICATION OF FOAM DARKENING OR DAMAGE. NEXT THE SYSTEM (PAD) IDENTIFIED AS MALFUNCTIONING WAS INVESTIGATED. THE WARMING SYSTEM WAS CONNECTED. THE LATERAL EDGE OF THE PAD, PREVIOUSLY DETECTED AS HOT, REGISTERED OVERTEMP +80C, THE REST OF THE PAD REMAINED COOL TO THE TOUCH. THE SYSTEM WAS DISCONNECTED AND THE PAD CUT OPEN TO EXAMINE . IT WAS QUICKLY APPARENT THAT THERE WAS HEAT DAMAGE TO THE FOAM ALONG THE LATERAL EDGE OF THE PAD- BENEATH THE BUS BAR. THE FOAM WAS DAMAGED AND DISCOLORED. THE REST OF THE FOAM PAD SHOWED NO DISCOLORATION OR DAMAGE. INITIAL INVESTIGATION OF THE HEATING ELEMENT ASSEMBLY OF THE PAD IT WAS IMMEDIATELY NOTED THAT ONLY 1 WIRE (BLACK) WAS CRIMPED TO THE ELEMENT BUS BAR THE 2ND WIRE (RED) WAS NOT CRIMPED TO THE OPPOSITE ELEMENT BUS BAR. THE RED WIRE CRIMP WAS CONNECTED TO THE WIRE, BUT WAS LAYING LOOSE, SANDWICHED BETWEEN THE FOAM. IT APPEARED TO HAVE NOT BEEN CONNECTED TO THE ELEMENT BUS. THE BLACK WIRE WAS SECURELY CRIMPED TO THE ELEMENT BUS BAR. THE HEATING ELEMENT HAS 2 BUS BARS THAT RUN VERTICALLY ALONG THE EDGE OF THE PAD. THE DAMAGE AND HEAT DISCOLORATION WAS ONLY BENEATH THE 1 BUS BAR AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318453 PINTLER PATIENT WARMING SYSTEM PINTLER PATIENT WARMING SYSTEM: PEAK PAD DWJ PINTLER MEDICAL, LLC PPWS001 27473

    Patients

    Seq Age Sex Outcome Treatment
    1