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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR INTELLICART SYSTEM

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DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR INTELLICART SYSTEM Back to Search Results
Model Number N/A
Device Problems Failure to Power Up; Smoking
Event Date 07/19/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device was evaluated by an external contractor. 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. Using crm to query for serial number (b)(4), the device was noted to have not been previously repaired by zimmer biomet surgical. On (b)(6) 2018, it was reported by (b)(6) hospital that the unit was smoking and then it was not turning on. Rep-lite was contacted about the issue and service technician was dispatched to the site. On 20 july 2018, the technician found that the power inlet module fuse was blown. So he replaced power inlet module and verified that the unit was functioning as intended and returned the unit to service. The device was tested, inspected, and repaired. The riverside technician confirmed that the smoking issue was due to blown fuse. But the technician was unable to duplicate the issue, since the part was damaged and he cannot test the issue. Service work order (b)(4) on (b)(4) 2018. Based on the information, the root cause of the reported issue was due to blown fuse in the entry module; which prevents voltage supply to cart and also caused the smoke issue too. The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the power inlet module was replaced. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. 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.

 
Event Description

It was reported that the unit was smoking and now it's not turning on. The event occurred after surgery. There was no patient involvement.

 
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Brand NameDUO FLUID CART WITH SMOKE EVACUATOR
Type of DeviceINTELLICART SYSTEM
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 Key7752480
Report Number0001954182-2018-00048
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 07/31/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number00514010200
Device LOT Number0025730
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/22/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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