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U.S. Department of Health and Human Services

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

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DORNOCH ULTRAFLEX DUO HIGH FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number ULDU500SE
Device Problem Output Problem
Event Date 02/25/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Evaluation and investigation is in process. Once the investigation is complete, a supplemental medwatch will be filed. Device evaluated by manufacturer? evaluated by external contractor.

 
Event Description

It was reported that the unit had a level sensor error for both cylinders. The unit also indicated incorrect information for fluid volume, as well as level sensor errors. The event timing was after cleaning. No adverse events were reported as a result of this malfunction.

 
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Brand NameULTRAFLEX DUO HIGH 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 Key8441100
Report Number0001954182-2019-00021
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberULDU500SE
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/25/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/13/2013
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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