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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, PORTABLE, AC-POWERED

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DORNOCH ULTRAFLEX DUO HIGH FLUID CART - REFURBISHED APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number ULDU500R
Device Problem Fluid Leak
Event Date 06/22/2018
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4). Pma/510k: 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. Using crm to query for serial number (b)(4), the device was noted to have been previously repaired 1 time, the previous repair being for drain error on cylinder #1 on (b)(6) 2016. The valve pack issue was not associated with the current repair service, so the previous repair was a non-related issue. On (b)(6) 2018, it was reported from (b)(6) hospital that the unit was leaking fluid during a case. Replete was contacted about the cart and dispatched a service technician to be at the site. The technician arrived at the site on (b)(6) 2018 and confirmed that the cart was leaking as he found that the lower sound material was wet. The technician pulled the material out and completely dried the inside of the unit, ran multiple wash cycles and could not find any leak and then replaced the duo lower sound material (part # 70011 and lot code # 0025579) and then verified that the cart was functioning as intended. The technician then returned the cart to service without further incident. The device was tested, inspected, and repaired. Service work order (b)(4) on (b)(6) 2018. While the service technician confirmed the reported event and the device was noted to be functioning as intended after the lower sound insulation material was replaced, it is unknown with the information provided from where the unit was leaking as the technician could not find any leak during troubleshoot. Therefore, based on the information provided, a specific root cause of the reported event cannot be determined. 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 was leaking fluid during surgery. No harm and no delay.

 
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Brand NameULTRAFLEX DUO HIGH 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 Key7746814
Report Number0001954182-2018-00043
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 07/20/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/03/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberULDU500R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/21/2015
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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