TI100 ROADRUNNER TI100RR 6734980

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2001-07-18 for TI100 ROADRUNNER TI100RR 6734980 manufactured by Hill-rom Air-shields.

Event Text Entries

[18834992] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2510954-2001-00012
MDR Report Key342758
Report Source01,08
Date Received2001-07-18
Date of Report2001-07-18
Date of Event1998-10-01
Date Added to Maude2001-07-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactLARRY KRASLEY
Manufacturer Street330 JACKSONVILLE RD
Manufacturer CityHATBORO PA 19040
Manufacturer CountryUS
Manufacturer Postal19040
Manufacturer Phone2156828688
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameTI100 ROADRUNNER
Generic NameTRANSPORT INCUBATOR SYSTEM
Product CodeFPL
Date Received2001-07-18
Model NumberTI100RR
Catalog Number6734980
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key332096
ManufacturerHILL-ROM AIR-SHIELDS
Manufacturer Address330 JACKSONVILLE RD. HATBORO PA 19040 US
Baseline Brand NameTI100 ROADRUNNER
Baseline Generic NameTRANSPORT INCUBATOR
Baseline Model NoTI100RR
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyTRANSPORT INCUBATOR
Baseline Shelf Life Contained*
Baseline Shelf Life [Months]*
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK924324
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2001-07-18

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