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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED APPARATUS, SUCTION, WARD USE

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DORNOCH ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED APPARATUS, SUCTION, WARD USE Back to Search Results
Model Number N/A
Device Problem Fluid Leak
Event Date 03/12/2018
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4). The k081047; k123188; k133786. The previous repair report for ultra duo flex fluid cart 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 report review found no issues with the device after repair and all verifications, inspections and tests were successfully completed. On (b)(6) 2018, it was reported from (b)(6) center that the unit was leaking. (b)(6) was contacted about the unit and dispatched the service technician to be at the site. On (b)(4) 2018, the technician replaced valve pack to resolve the issue. Then he found lower sound material was saturated and fan was shorted out. He replaced the sound material and fan. He then examined the unit and found that the vacuum pump was tripping gfi breaker. Since considering the volume of the workload in this unit, the unit was decided to exchange and process was initiated. An exchange for the new cart was scheduled. A new cart was shipped from (b)(4) to the facility. The new cart was confirmed to have been delivered to the facility and service company was dispatched a service technician to the site to perform exchange. On (b)(4) 2018, the technician arrived at the site and installed the new cart. He then verified that the cart was functioning as intended and placed the cart into service without further incident. The technician then repackaged the old cart so that it returned to service center. The exchanged cart was picked up from the facility. The exchange cart was confirmed to have been returned on 22 march 2018 and it was scrapped without any further evaluation as noted in a return equipment log. Service work order (b)(4) on 12 march 2018. Based on the information, the root cause of the reported issue was due to the valve pack malfunctioning. The reported event was confirmed during inspection of the device. The valve can leak fluid if the valve pack is not seated properly with the bottom plate or if there is improper sealing with the o-ring. When the fluid was leaked from the valve pack, it can damage sound material, fan, vacuum pump and other electrical component which located at the bottom part of the unit. Since several components were damaged due to the leak, it was exchanged. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Device evaluated by contractor.

 
Event Description

It was reported that the unit was found to be leaking during a case. The event occurred during surgery. Follow up indicated that the valve pack was leaking fluid during surgery. No adverse events were reported as a result of this malfunction.

 
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Brand NameULTRAFLEX DUO HIGH FLUID CART - REFURBISHED
Type of DeviceAPPARATUS, SUCTION, WARD USE
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 Key7381154
Report Number0001954182-2018-00022
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 03/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberULDU500R
Device LOT NumberN/A
OTHER Device ID Number(01)00889024465824
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/12/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/03/2017
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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