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U.S. Department of Health and Human Services

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

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DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR - REFURBISHED APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010200
Device Problem Smoking
Event Date 10/02/2019
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4). The investigation is still in progress. Once the investigation is complete a follow up mdr will be submitted.

 
Event Description

It was reported that during surgery it was reported that the unit was smoking but did not result in harm or injury. No delay occurred.

 
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Brand NameDUO FLUID CART WITH SMOKE EVACUATOR - 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 Key9238224
Report Number0001954182-2019-00069
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/25/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00514010200
Device LOT Number0027118
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 Received01/07/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/30/2018
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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