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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV, REFUBISHED; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV, REFUBISHED; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Model Number N/A
Device Problem Device Emits Odor (1425)
Patient Problem No Patient Involvement (2645)
Event Date 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.
 
Event Description
It was reported that during cleaning the cart was just installed and it has a burning smell to it.No adverse event was reported as a result of this malfunction.
 
Event Description
The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).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 Name
DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV, REFUBISHED
Type of Device
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Manufacturer (Section D)
DORNOCH
200 northwest parkway
riverside MO 64150
MDR Report Key9819285
MDR Text Key194602529
Report Number0001954182-2020-00016
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
PMA/PMN Number
K162421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberUE514010400
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/09/2020
Initial Date FDA Received03/11/2020
Supplement Dates Manufacturer Received04/01/2020
Supplement Dates FDA Received04/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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