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U.S. Department of Health and Human Services

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

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DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010200
Device Problem Device Emits Odor (1425)
Patient Problem No Patient Involvement (2645)
Event Date 07/29/2019
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).The previous repair record for intellicart system serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair.The previous repair record review found no issues with the device after repair and all verifications, inspections and tests were successfully completed.On july 29, 2019 it was reported from (b)(6) that the unit had smells like something was burning.On june 29, 2019 a zimmer biomet authorized service technician was contacted and dispatched to be at the site.Upon investigation, the technician troubleshot and found that the vacuum pump won't come on, and the unit gives vacuum sensor errors.Fuses were checked and were good.He replaced the vacuum pump (part# 70098, lot code 0040609).The device was tested, inspected, and repaired.Service work order (b)(4) on july 29, 2019.While the service technician was able to return the device to service after replacing the vacuum pump to address the vacuum sensor error he discovered during his investigation, this vacuum pump resolution is unrelated to the reported event of there being a burning-like smell.A specific root cause of the reported event can therefore neither be determined nor confirmed as we cannot say for sure if there is a connection between the discovered vacuum sensor error and the reported burning smell.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.
 
Event Description
It was reported that a duo fluid cart had smells like something was burning.No adverse events were reported as a result of this malfunction.
 
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Brand Name
DUO FLUID CART WITH SMOKE EVACUATOR
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 Key8873995
MDR Text Key162127154
Report Number0001954182-2019-00048
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/07/2019
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 Catalogue Number00514010200
Device Lot Number0026114
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/29/2019
Initial Date FDA Received08/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Removal/Correction NumberN/A
Patient Sequence Number1
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