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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Model Number N/A
Device Problem Fluid Leak
Event Date 06/04/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). K081047; k123188; k133786. The investigation is still in progress. Once the investigation is complete a follow up mdr will be submitted.

 
Event Description

It was reported that the unit was leaking fluid from the bottom. The event occurred during surgery.

 
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Brand NameULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
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 Key7579849
Report Number0001954182-2018-00036
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Type of Report Initial,Followup,Followup
Report Date 06/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/07/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00514010100
Device LOT Number0027358
OTHER Device ID Number(01)00889024465992
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/13/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured02/27/2018
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

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