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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; SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT

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DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV; SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT Back to Search Results
Model Number N/A
Device Problems Melted (1385); Device Emits Odor (1425)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
Event Type  malfunction  
Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).A follow up/ final report will be submitted once investigation is complete.
 
Event Description
It was reported that the unit smelled like it was very hot.There was burning on power inlet module.The event timing was after surgery.There was no harm or delay reported.No adverse events were reported as a result of this malfunction.
 
Event Description
There is no additional information.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).This medwatch is being filed to relay additional information.Review of the most recent repair record determined the power inlet module was melted and the fuses were blown.The power inlet module was replaced and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
 
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Brand Name
DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV
Type of Device
SURGICAL FLUID/SMOKE WASTE MANAGEMENT SYSTEM SUCTION UNIT
Manufacturer (Section D)
DORNOCH
200 northwest parkway
riverside MO 64150
MDR Report Key12354651
MDR Text Key267711507
Report Number0001954182-2021-00052
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
PMA/PMN Number
K190789
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 10/13/2021
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 Number00514010400
Device Lot Number45670
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/10/2021
Initial Date FDA Received08/23/2021
Supplement Dates Manufacturer Received10/12/2021
Supplement Dates FDA Received10/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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