BEUDAMED
    FDA Adverse Event Death Summary report: N

    TI100 ROADRUNNER

    MDR report key: 342758 · Received July 18, 2001

    Report

    Report Number
    2510954-2001-00012
    Event Type
    Death
    Date Received
    July 18, 2001
    Date of Event
    October 1, 1998
    Report Date
    July 18, 2001
    Manufacturer
    HILL-ROM AIR-SHIELDS
    Product Code
    FPL
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORT ALLEGES THAT AN INCIDENT OCCURRED IN 1998 THAT RESULTED IN THE DEATH OF A PT FOLLOWING AN AIR TRANSPORT. AN INCIDENT OCCURRED IN 1998 RESULTING IN THE DEATH OF A PT. THE PT DIED SOME TIME AFTER ADMISSION TO THE HOSP AFTER BEING RETRIEVED BY AIR AMBULANCE FROM ANOTHER HOSP. PREMATURE TWINS WERE DELIVERED BY CAESARIAN SECTION AT ABOUT 24 WEEKS GESTATION. THE MOTHER PRESENTED AT THE HOSP NOT KNOWING THAT MOTHER WAS PREGNANT AND THEREFORE HAD NO ANTENATAL CARE PRIOR TO ARRIVING IN THE EMERGENCY DEPT. THE BIRTH OCCURRED AT ABOUT 21:29 IN 1998. A DECISION WAS MADE TO TRANSPORT ONE PT TO ANOTHER HOSP. PT TO BE TRANSPORTED WAS ABOUT 650 GRAMS AT BIRTH. THE RETRIEVAL TEAM ARRIVED AT ABOUT 04:00 THE NEXT DAY AND THE PT'S TEMPERATURE WAS MEASURED AT 33 DEGREES CELSIUS. THE PT WAS PLACED IN A TI-100 ROAD RUNNER AND TRANSFERRED BY ROAD AMBULANCE TO AIRPORT WHEREUPON THE TI-100 RR WAS TRANSFERRED TO A WAITING FIXED WING AIR AMBULANCE. EVENTHOUGH THE DISTANCE TO THE HOSP IS SHORT AND A ROTARY WING AIRCRAFT WOULD NORMALLY BE USED SEVERE BAD WEATHER DICTATED A FIXED WING TRANSFER. THE WEATHER CONDITIONS THAT NIGHT WERE DESCRIBED AS AN ATROCIOUS STORM. THE RETURN FLIGHT WAS VERY TURBULENT. IT IS UNCLEAR IF THE TOTAL TRANSFER TIME (HOSPITAL TO HOSPITAL) WAS 3 OR 4 HOURS. THE ATTENDING NURSE REPORTED (A WEEK LATER IN WRITING) THAT THE A/C POWER IN THE AIRCRAFT "FAILED" AT SOME TIME DURING THE FLIGHT. ALTHOUGH ON READING NURSE'S REPORT IT IS UNCLEAR IF THE AIRCRAFT'S AUX. POWER FAILED OR THEY FAILED TO CONNECT THE TRANSPORT SYSTEM TO USE THE AIRCRAFT'S POWER SUPPLY. THE NURSE REPORTED THAT AT SOME POINT IN THE RETURN FLIGHT AN ALARM OCCURRED DESCRIBED AS 'FAN FAIL/OVERHEAT'. THE TI-100 RR WAS SWITCHED INTO STAND BY MODE TO 'COOL DOWN' AS NURSE BELIEVED IT HAD OVERHEATED. SOME ATTEMPT TO CLOTHE THE PT WAS MADE TO KEEP IT WARM. THE AIRCRAFT'S CABIN TEMP WAS DESCRIBED AS LOW AND COULD NOT BE INCREASED. THE NURSE AND ATTENDING DR TRIED TO TURN THE TI-100 RR BACK ON A FEW TIMES ONLY TO REPEAT THE ALARM CONDITION. THE PT'S TEMP WAS RECORDED ON ARRIVAL AT HOSP AT 33 DEGREES CELSIUS. THE PT DIED SOME TIME LATER, PROBABLY THE NEXT DAY. THE HOSP'S BIO-MED CHECKED THE TI-100 RR AFTER ITS RETURN TO HOSP AND FOUND NO FAULT WITH THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32460 TI100 ROADRUNNER TRANSPORT INCUBATOR SYSTEM FPL HILL-ROM AIR-SHIELDS TI100RR *

    Patients

    Seq Age Sex Outcome Treatment
    1 Death