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Adverse Event Report

ALLEGIANCE HEALTHCARE FISCHER PAKEL/ALLEGIANCE 9054-452: NEONATAL HEATED CIRCUIT   back to search results
Model Number 9054-4 S 2
Patient Outcome  Required Intervention;
Event Description

Heated wire ventilator circuit overheated immediately, melting circuit. Pt was not involved. Staff member slightly burned hand shutting device down (plastic on circuit melted). Infant breathing circuit.

 
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Brand NameFISCHER PAKEL/ALLEGIANCE
Type of Device9054-452: NEONATAL HEATED CIRCUIT
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE
23 maple st
norfolk MA 02056
Device Event Key307551
MDR Report Key318034
Event Key299012
Report NumberMW1021205
Device Sequence Number1
Product CodeBZE
Report Source Voluntary
Report Date 02/20/2001
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/2001
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number9054-4 S 2
Device LOT NumberYOA2341-00360 OR YON2077-00165
Was Device Available For Evaluation? Yes
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided

Database last updated on January 30, 2009

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