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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
Model Number N/A
Device Problem Fluid Leak
Event Date 02/27/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Pma/510(k): k081047; k123188; k133786. This medwatch is being filed to relay additional information. The following sections were it was reported from (b)(6) hospital that a unit was setting off the or electrical panel alarm with leakage >1000ma. On 27 february 2018, replite was contacted about the cart and dispatched a service technician to be at the site. The technician arrived at the site and found current leakage caused by damaged fan that was damaged from a valve pack leak. He replaced the fan reseated the valve pack, 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 setting off the or electrical panel alarm was due to current leakage from a damaged fan, which was caused by a leaking valve pack. Fluid would damage the electrical circuits of the fan unit, leading to current leakage, which in turn would trip the electrical panel alarm. The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the valve pack was reseated and the fan was replaced. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Evaluated by external service technician.

 
Event Description

It was reported that the ultra duo high fluid cart was setting off the or electrical panel. It stated that fluid was leaking during surgery. No adverse events were reported as a result of this malfunction.

 
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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 Key7351341
Report Number0001954182-2018-00020
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 03/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/19/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberULDU500
Device LOT NumberN/A
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured07/15/2014
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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