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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH DUO FLUID CART - REFURBISHED APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH DUO FLUID CART - REFURBISHED APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number UE514010100
Device Problem Smoking
Event Date 09/21/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Device evaluation: the unit was evaluated by an external contractor. Conclusion: the vacuum pump tube was touching the brass elbow of the vacuum pump; this caused the tube to heat up and smoke. The device history record (dhr) review for intellicart system serial number (b)(4), noted no related non-conformances, requests for deviation (rfd), change notices (cn), or any other issues with manufacturing. The dhr review found no issues with the device and all verifications, inspections, and tests were successfully completed. On (b)(6) 2018, it was reported by (b)(6) hospital that the unit had a vacuum that was smoking. Replite was contacted about the issue and service technician was dispatched to the site. On (b)(4) 2018, technician found that the vacuum tube was touching the brass elbow of the vacuum pump. So he tied the vacuum tubing away from the brass elbow of the pump with the help of a zip-tie and verified that the unit was functioning as intended and return the unit back to service. The device was tested, inspected, and repaired. Based on the information, the root cause of the reported issue was due to vacuum pump tube was touching the brass elbow of the vacuum pump; which tends to heat up. Since the tube was touching the hot elbow, it would cause the tube to singe and generate a smoke smell. The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the vacuum pump hose was tied away from vacuum pump brass elbow using a zip-tie. 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 the unit had a vacuum that was smoking. The account alleged that the cart was emitting a smoke like smell. The event timing was prior to surgery. No adverse events were reported as a result of this malfunction.

 
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Brand NameDUO FLUID CART - REFURBISHED
Type of DeviceAPPARATUS, 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 Key7966428
Report Number0001954182-2018-00066
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 10/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUE514010100
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/29/2018
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

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