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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 Problems Device Emits Odor (1425); Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once an evaluation of this device is completed, a follow-up/final report will be submitted.
 
Event Description
It was reported this cart was smoking and giving off a burning odor during surgery.Burning/charring/scorching was present, though all damage was relegated to the power inlet module and the power cord and there was no patient involvement and no harm/injury to operator.No adverse events were reported as a result of this malfunction.
 
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 that the cart would not turn on when plugged in, and there were signs of excess heat.The power inlet module, wires, and power cord were replaced and resolved the reported issue.-device is used for treatment.-a definitive root cause cannot be determined.-the event is confirmed.
 
Event Description
There is no additional information.
 
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Brand Name
DUO FLUID CART
Type of Device
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Manufacturer (Section D)
DORNOCH
200 northwest parkway
riverside MO 64150
MDR Report Key11822487
MDR Text Key250542930
Report Number0001954182-2021-00026
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
PMA/PMN Number
K172481
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 07/01/2021
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 Number00514010100
Device Lot Number0024334
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/07/2021
Initial Date FDA Received05/13/2021
Supplement Dates Manufacturer Received06/30/2021
Supplement Dates FDA Received07/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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