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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH ULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number ULDU500
Device Problems Mechanical Problem; Output Problem
Event Date 07/18/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Pma 510(k): k081047; k123188; k133786. The device history record (dhr) for ultra duo flex fluid cart serial number (b)(4) was reviewed and 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 from (b)(6) that 4 units where down. (b)(4) mechanical was contacted about the cart and dispatched a service technician to be at the site. The technician arrived at the site and found that the unit was not measuring fluids correctly, and noted that unit a/d values were above 6000 on both cylinders and the unit was not draining completely. He replaced both level sensors 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. The root cause for the unit having being down was due to malfunctioning level sensors in both cylinders. The level sensors are responsible for measuring the fluid levels in each cylinder, and a malfunctioning level sensor would not allow the unit to function as designed. The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the level sensors were 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 during site inspection, the unit was found to have a bad level sensor. During investigation, it was discovered that both level sensors were replaced.

 
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Brand NameULTRA DUO HIGH FLUID CART NON-STERILE INSTRUCTIONS FOR USE
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 Key7946620
Report Number0001954182-2018-00064
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 10/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberULDU500
Device LOT Number0019879
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/02/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/02/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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