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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; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV; 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 09/15/2021
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 the unit had a strong odor of a burnt smell after being plugged in.Follow up determined that both smoke and a burnt odor were present.Event occurred during surgery but there was no patient harm or delay that occurred.An additional device was used to complete the procedure.No adverse events were reported as a result of this malfunction.
 
Event Description
No further event information available at the time of this report.
 
Manufacturer Narrative
This follow-up is being submitted to relay additional information.The results of the investigation are as follows: review of the most recent repair record identified no repairs related to the reported event.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV
Type of Device
APPARATUS, 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 Key12669511
MDR Text Key277594291
Report Number0001954182-2021-00065
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/08/2022
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 Number45487
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/21/2021
Initial Date FDA Received10/20/2021
Supplement Dates Manufacturer Received02/07/2022
Supplement Dates FDA Received02/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2021
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
Patient Sequence Number1
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