TRAILBLAZER TRANSPORT INCUBATOR TI 100 NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-21 for TRAILBLAZER TRANSPORT INCUBATOR TI 100 NA manufactured by Hill-rom Air-shields.

Event Text Entries

[132791] Problem: fire hazard when operated from the vehicle 12v supply. Action: when connecting an external dc supply to the incubator ensure that: the positive and negative leads are clearly distinguishable, any mains cables connected to the incubator or equipment connected to it are removed, the negative lead connection is made first, and the negative lead connection is secure. When disconnecting the incubator from the external dc supply ensure that the positive connector is removed first. Ensure that these instructions are included in all local protocols for the transport of neonates and ensure that staff are aware that failure to follow this instruction could at worst result in fire and at least in serious injury from smoke inhalation. Consideration should be given to early replacements of these units. Background: when the incubator is used in an ambulance an electrical return path may be created between the incubator and the vehicle. Connection of the 12v supply terminal may result in a fire hazard. 1. The wiring in a trailblazer incubator melted and produced smoke when the positive terminal was connected to the ambulance supply. 2. The trailblazer incubator does not comply with iec 601-1 in that its external negative supply is connected to its chassis. 3. If the external positive supply is connected but the external negative supply has not been connected, current can flow through the anchor points of the incubator or any trailing mains leads earth pins to the ambulance chassis. Because this path is not intended to carry a high current damage to the negative wiring in the incubator may occur. 4. Connecting the negative supply first will ensure an adequate return path for the current. 5. In this instance the 12v leads were not clearly color coded in that the color flashes were easily obscured by the operator's hand. 6. Additionally, users should be aware that connecting the negative supply lead to the vehicle positive supply will result in high current flow and the probability of fire.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW4002194
• MDR Report Key: 163389
• Date Received: 1998-04-21
• Date of Report: 1998-03-01
• Date Added to Maude: 1998-04-22
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TRAILBLAZER TRANSPORT INCUBATOR
• Generic Name: TRANSPORT INCUBATOR
• Product Code: FPL
• Date Received: 1998-04-21
• Model Number: TI 100
• Catalog Number: NA
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 159055
• Manufacturer: HILL-ROM AIR-SHIELDS
• Manufacturer Address: 330 JACKSONVILLE RD HATBORO PA 19040 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		1998-04-21