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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
Model Number N/A
Device Problem Improper Device Output
Event Date 04/06/2018
Event Type  Malfunction  
Manufacturer Narrative

This event is recorded with zimmer biomet under (b)(4). Pma#: k081047; k123188; k133786. The device was evaluated by an external contractor. The device history record (dhr) review for ultra duo flex fluid cart serial (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 (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) medical center that the unit¿s cylinder #1 was not functioning. (b)(6) was contacted about the issue with cart and technician was dispatch to the site. On (b)(6) 2018, the technician found that the unit¿s level sensor lost it calibration and then he ordered control board. On 11 april 2018, he replaced the control board with a duo control board kit 4. 3 (part#91940, lot#0027765) and verified that the unit was functioning as intended and then returns the cart to service. The device was tested, inspected, and repaired. Service work order (b)(4) on (b)(6) 2018. Based on the information, the root cause of the reported issue was due to a control board in the cart malfunctioning. When the control board malfunctions, it won¿t properly communicate with sub-component which includes level sensors which causes level sensor to read inaccurate fluid levels. The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the control board was replaced. 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 #1 cylinder would not function. It was found out that the calibration of both level sensors was lost. The event timing was post surgery. No adverse consequences have been reported as a result of this malfunction.

 
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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 Key7635767
Report Number0001954182-2018-00037
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial
Report Date 06/25/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/25/2018
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 Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/12/2018
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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