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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 Melted; Smoking
Event Date 04/09/2019
Event Type  Malfunction  
Manufacturer Narrative

This event has been recorded by zimmer biomet under (b)(4). On (b)(6) 2019, it was reported from (b)(6) medical center that a duo cart unit was smoking. Per followup, the unit had a melted power inlet module. On (b)(6) 2019, (b)(4) 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 power inlet module of the unit had failed and melted. The technician replaced the power inlet module (part #90204) and then verified that the unit was functioning as intended. The technician then returned the unit to service without further incident. The device was tested, inspected, and repaired as per cl ¿ repair cart and evac rev. 0. Service work order (b)(4) on (b)(6) 2019. Although the reported event of the unit smoking and the power inlet module melting was confirmed during inspection of the device, and the device was noted to be functioning as intended after the power inlet module was replaced, it is not known with the information available what caused the power inlet module to melt to begin with. Therefore, based on the information provided, the 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 power inlet module melted. The power inlet was replaced and returned to service. The event occurred before surgery. No adverse events were reported as a result of this malfunction. No additional event information available.

 
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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 Key8561626
Report Number0001954182-2019-00029
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 04/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberULDU500
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/09/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2013
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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