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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

(b)(4). The device within the complaint was noted to have been conforming as intended during inspection of the device. As there is no non-conformances with the device, no device history records review, previous repair review, or complaint history review is required to be performed and no previous repair record is required to be attached to the complaint. On (b)(6) 2018, it was reported from (b)(6) hospital that the unit was leaking fluid during a case. Replite was contacted about the cart and dispatched a service technician to be at the site. The technician arrived at the site on (b)(4) 2018 and opened back of the cart and found no liquids or could not find any sort of leaking fluid. The technician 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)(4) 2018. The service technician could not reproduce the reported event. 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. Device evaluated by external contractor.

 
Event Description

It was reported that unit was leaking fluid during a case. The event occurred during surgery. No harm and no delay was reported.

 
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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 Key7753026
Report Number0001954182-2018-00047
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 07/17/2018
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 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 Received07/16/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/15/2015
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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