BEUDAMED
    FDA Adverse Event Injury Summary report: N

    READY-HEAT

    MDR report key: 9233890 · Received October 24, 2019

    Report

    Report Number
    3005346101-2019-00001
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    September 12, 2019
    Report Date
    November 11, 2020
    Manufacturer
    TECHTRADE LLC
    Product Code
    KME
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REVIEW OF ALL INCOMING PRODUCT AND SPECIFIC LOT CODE PRODUCT SHOW THAT THE ITEM WAS MADE AND TESTED TO SPECIFICATION UPON RECEIPT. NO ADDITIONAL INCIDENT REPORTS FROM ANY OTHER USER. SPOKE WITH NURSE PRACTITIONER FROM GOVERNMENT AGENCY AND EMT SUPERVISOR TO GET MORE DETAILS AND FROM WHAT HAS INITIALLY BEEN GATHERED THE INCIDENT APPEARS TO BE CAUSED BY USER ERROR AND NEGLIGENCE. THE INFANT WAS NOT CHECKED DURING THE RIDE AND ONLY UPON ARRIVAL AT THE HOSPITAL DID THE STAFF NOTICE THAT THE INTERVENING LAYER HAD MOVED AND BURNS HAD DEVELOPED. ASKED FOR ITEMS TO BE RETURNED FOR FURTHER INVESTIGATION. DEVICE IN QUESTION WAS NO LONGER AVAILABLE TO REVIEW. INCOMING INSPECTION REPORTS FOR THE BATCH NUMBER INDICATED AS WELL AS THE BATCHES BOTH IMMEDIATELY BEFORE AND AFTER THIS LOT WERE ALL INSPECTED AND TESTED AFTER PRODUCTION. THIS DATA IS AVAILABLE AND SHOWS THAT ALL PRODUCTS WERE MADE CORRECTLY, WITH ACCURATE COMPONENTS AND MANUFACTURED TO SPECIFICATION. POST MARKET SURVEILLENCE SHOWS NO ADDITIONAL INCIDENTS, COMPLAINTS, COMMENTS, EVENTS, ETC, AFTER WAITING 1 YEAR FROM DATE OF INCIDENT. BASED ON INITIAL REPORT AND ALL EVIDENCE AVAILABLE THE PRODUCT DID NOT MALFUNCTION. THERE IS A KNOWN RISK OF SURFACE BURN WHICH IS INDICATED AND ADDRESSED WITHIN THE IFU AND WARNINGS BUT THE INSTRUCTIONS AND WARNINGS WERE NOT FOLLOWED. WE WILL CONTINUE TO MONITOR INCOMING COMPLAINTS AND POST MARKET SURVEILLANCE AND IF ANY FUTURE INCIDENT IS REPORTED WE WILL PERFORM ADDITIONAL ROOT CAUSE ANALYSIS.

    Description of Event or Problem · 0

    AS RELAYED TO OUR OFFICE VIA EMAIL, PHONE CONVERSATION AND MEDWATCH REPORT: NEWBORN INFANT WAS DELIVERED IN HOME. INFANT WAS REQUIRED TO BE TRANSPORTED TO THE HOSPITAL. READY-HEAT DEVICE WAS APPLIED BY FIREFIGHTERS IN HOME SETTING FOR UNDETERMINED AMOUNT OF TIME. INFANT HELD WITH DEVICE APPLIED BY BOTH MOTHER AND FATHER BEFORE AMBULANCE ARRIVED. READY-HEAT PRODUCT WAS TAKEN INTO THE AMBULANCE WITH THE INFANT AND PLACED UNDER THE INFANT ON A STRETCHER AND INSIDE OF AN ACR WHERE THE INFANT WAS STRAPPED DOWN TO THE DEVICE. SOME REPORTS ADMIT THAT THE INTERVENING LAYER BETWEEN THE PATIENT AND THE HEATING ELEMENT HAD MOVED DURING TRANSPORT, OTHERS DO NOT. ONE REPORT ASSERTS THAT THE INFANT WAS PLACED ON BLOW BY OXYGEN. THE ACTUAL EVENTS ARE UNCLEAR. THE INFANT WAS IN THE RESTRAINT DEVICE ON TOP OF THE BLANKET FOR AN ESTIMATED 30 MINUTES WITHOUT INTERVENTION OR SUPERVISION. UPON ARRIVAL AT THE HOSPITAL, BURNS TO THE SHOULDER AND COCCYX AREA WERE DISCOVERED. ONE REPORT SAYS 9% AND ANOTHER STATES 10-12% BURN. MEDICAL INTERVENTION WAS REQUIRED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    WAITING TO RECEIVE EITHER DEVICE IN QUESTION OR ADDITIONAL DEVICES WITH THE SAME LOT NUMBER AS DELIVERED TO INITIAL REPORTER. INITIAL REQUEST MADE AT TIME OF REPORT. FOLLOW UP MADE AT TIME OF THIS REPORT. THERE WERE TWO MEDWATCH REPORTS WE RECEIVED, BOTH DETAILING THE SAME INCIDENT. THE REPORT NUMBERS ASSOCIATED WITH THEM ARE MW5089968 AND MW5090088. THE DEVICE WAS INITIALLY EVALUATED AFTER MANUFACTURE AND WAS FOUND TO BE IN COMPLIANCE WITH ALL SPECS. IT WAS TESTED FOR TEMPERATURE, MATERIAL COMPOSITION AND CORRECT ASSEMBLY. ONCE SAMPLES FROM INITIAL REPORTER ARE RECEIVED THEY CAN BE TESTED AND COMPARED TO THE INITIAL EVALUATION.

    Description of Event or Problem · 1

    AS RELAYED TO OUR OFFICE VIA EMAIL, PHONE CONVERSATION AND MEDWATCH REPORT: NEWBORN INFANT WAS DELIVERED IN HOME. INFANT WAS REQUIRED TO BE TRANSPORTED TO THE HOSPITAL. READY-HEAT DEVICE WAS APPLIED BY FIREFIGHTERS IN HOME SETTING FOR UNDETERMINED AMOUNT OF TIME. INFANT HELD WITH DEVICE APPLIED BY BOTH MOTHER AND FATHER BEFORE AMBULANCE ARRIVED. READY-HEAT PRODUCT WAS TAKEN INTO THE AMBULANCE WITH THE INFANT AND PLACED UNDER THE INFANT ON A STRETCHER AND INSIDE OF AN ACR WHERE THE INFANT WAS STRAPPED DOWN TO THE DEVICE. SOME REPORTS ADMIT THAT THE INTERVENING LAYER BETWEEN THE PATIENT AND THE HEATING ELEMENT HAD MOVED DURING TRANSPORT, OTHERS DO NOT. ONE REPORT ASSERTS THAT THE INFANT WAS PLACED ON BLOW BY OXYGEN. THE ACTUAL EVENTS ARE UNCLEAR. THE INFANT WAS IN THE RESTRAINT DEVICE ON TOP OF THE BLANKET FOR AN ESTIMATED 30 MINUTES WITHOUT INTERVENTION OR SUPERVISION. UPON ARRIVAL AT THE HOSPITAL, BURNS TO THE SHOULDER AND COCCYX AREA WERE DISCOVERED. ONE REPORT SAYS 9% AND ANOTHER STATES 10-12% BURN. MEDICAL INTERVENTION WAS REQUIRED. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026622 READY-HEAT READY-HEAT INFANT WARMING MATTRESS KME TECHTRADE LLC S2RHIM 18183M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| S