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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 05/18/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device was evaluated by an external contractor. The previous work order in customer relationship management (crm) for ultra duo flex fluid cart serial number (b)(4) was reviewed and noted no related non-conformances, requests for deviation (rfd) or any other issues with the repair. The previous work order noted no issues with the device after repair and all verifications, inspections and tests were successfully completed. Using crm to query for serial number (b)(4), the device was noted to have been previously repaired two times, the previous repair being for an issue with the cl500 housing on 09 november 2016. The cl500 housing is not associated with the current repair. Thus, this repair was a non-related issue. On (b)(6) 2018, it was reported from (b)(6) that a unit will at times indicate full when it is empty and a pm timer warning populates even though the unit was recently pm'ed. On (b)(6) 2018, (b)(4) was contacted about the cart and dispatched a service technician to be at the site. The technician arrived at the site and was unable to confirm that the cart was reading full when it was empty, but noted tandem warnings on cylinder 1. He replaced the cylinder 1 level sensor (part # 81584, lot code 0027381), reset the pm timer, 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 as per cl ¿ repair cart and evac rev. 0. Service work order (b)(4) on (b)(6) 2018. The reported event of the unit reading full when empty was never confirmed during inspection of the device. Therefore the root cause of the unit reading full when empty could not be determined. The reported event of the unit issuing pm timer warnings was confirmed during inspection of the device, however it cannot be determined from the information provided what caused the pm timer to populate. Therefore the root cause of the unit issuing pm timer warnings could not 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 unit will at times indicated full when it is empty. The pm timing warning populates as well. The event timing was during cleaning. No adverse events were 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 Key7554142
Report Number0001954182-2018-00033
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 05/30/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/30/2018
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 NumberN/A
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/29/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/31/2016
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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