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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010200
Device Problem Fluid Leak
Event Date 07/05/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Once the investigation has been completed, a follow up mdr will be submitted.

 
Event Description

It was reported that unit was leaking from bottom of cart. The event occurred during surgery. There was no harm and no delay. No adverse events were reported as a result of this malfunction.

 
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Brand NameDUO FLUID CART WITH SMOKE EVACUATOR
Type of DeviceAPPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Manufacturer (Section D)
DORNOCH
200 northwest parkway
riverside MO 64150
Manufacturer (Section G)
DORNOCH
200 northwest parkway
riverside MO 64150
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw , IN 46582
5745273773
MDR Report Key7745462
Report Number0001954182-2018-00050
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 09/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00514010200
Device LOT Number0026318
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/12/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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