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U.S. Department of Health and Human Services

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

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DORNOCH ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Model Number N/A
Device Problem Fluid Leak
Event Date 11/29/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Once the investigation is complete, a follow up/final report will be submitted.

 
Event Description

Ultraflex duo high fluid cart had a spray head in cylinder 1 that appears to not be rotating and spraying correctly. Cylinder 2 was leaking from the manifold housing. No adverse events were reported as a result of this malfunction.

 
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Brand NameULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
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 Key8168989
Report Number0001954182-2018-00078
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberULDU500R
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/07/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/10/2016
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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