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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 (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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
MDR Text Key110457476
Report Number0001954182-2018-00036
Device Sequence Number1
Product Code JCX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberPK162421
Number of Events Reported1
Summary Report (Y/N)N
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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