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Adverse Event Report

CARDINAL HEALTH PEDIATRIC HEATED CIRCUIT 9FT HEATED WIRE CIRCUIT   back to search results
Model Number 10799-H12
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Account states customer getting low airway lemp alarms. Felt tubing was hot. Replaced immediately found old circuit had heated wires all bunched up in one spot, started to melt tubing.

 
Manufacturer Narrative

The product sample was received for evaluation and the reported issue was confirmed. Review of the sample found that the wire was bunched in one spot causing the wire to overheat on this spot melting the tubing. A probable root cause may be due to an assembly error by the manufacturing personnel. Manufacturing personnel have been made aware of the reported issue in order to prevent this type of failure in the future.

 
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Brand NamePEDIATRIC HEATED CIRCUIT 9FT
Type of DeviceHEATED WIRE CIRCUIT
Baseline Brand NamePEDIATRIC HEATED CIRCUIT 9FT
Baseline Generic NameHEATED WIRE CIRCUIT
Baseline Catalogue Number10799-H12
Baseline Model Number10799-H12
Baseline Device FamilyVENTILATION CIRCUIT
Baseline Device 510(K) NumberK993833
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed12/10/1999
Manufacturer (Section F)
CARDINAL HEALTH
1430 waukegan road
mcgaw park IL 60085
Manufacturer (Section D)
CARDINAL HEALTH
1430 waukegan road
mcgaw park IL 60085
Manufacturer Contact
patricia sharpe-greg
1430 waukegan road
mcgaw park , IL 60065
(847) 578 -4148
Device Event Key457797
MDR Report Key468897
Event Key444408
Report Number1423507-2003-00084
Device Sequence Number1
Product CodeBZE
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation RESPIRATORY THERAPIST
Type of Report Initial
Report Date 06/26/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number10799-H12
Device Catalogue Number10799-H12
Device LOT NumberY3C1731
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/27/2003
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device? No Answer Provided
Type of Device Usage Unkown

Database last updated on January 06, 2009

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