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U.S. Department of Health and Human Services

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

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DORNOCH DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Model Number N/A
Device Problem Fluid Leak
Event Date 08/07/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The product will be evaluated by an external contractor and is in process for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.

 
Event Description

It was reported that the duo fluid cart was leaking from the top of cylinder #2. The event occurred during surgery. No adverse events have been reported as a result of this malfunction.

 
Manufacturer Narrative

Upon receipt of additional information, it has been determined that this device did not cause or contribute serious injury and has not been previously reported as a serious injury. The initial report was forwarded in error and should be voided.

 
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Brand NameDUO FLUID CART
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 Key7785838
Report Number0001954182-2018-00054
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 08/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2018
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 NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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