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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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DORNOCH DUO FLUID CART APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010100
Device Problem Smoking
Event Date 05/21/2019
Event Type  Malfunction  
Manufacturer Narrative

This event is recorded by zimmer biomet under (b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet. Once the product is returned and the investigation is complete, a follow up/final report will be submitted.

 
Event Description

It was reported that the duo fluid cart may have started smoking while in use. The event occurred during cleaning. There was no patient involvement. No adverse events were reported as a result of this malfunction.

 
Manufacturer Narrative

(b)(4). The previous repair record for intellicart system 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 repair record review found 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 twice, the previous repair being for the valve pack on (b)(6) 2019. This is not associated with the current repair. Thus, this repair was a non-related issue. On (b)(6) 2019 it was reported from fresno surgical hospital that the unit may have started smoking while in use. On (b)(6) 2019 a zimmer biomet authorized repair technician was contacted about the cart and dispatched to be at the site. The technician arrived but was not able to duplicate the issue. With the board and power supply both requiring replacement, he proceeded to replace the control board and power supply and then tested the unit to verify proper operation. The device was tested, inspected, and repaired. Although the service technician was unable to duplicate the reported event, he did however proceed to replace the power supply and control board because they both required replacement. A root cause for the reported event, therefore, cannot be determined. Afterwards, the device was noted to be functioning without any issue. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process. Device evaluated by manufacturer? evaluated by external contractor.

 
Event Description

No additional event information available.

 
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Brand NameDUO FLUID CART
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 Key8649899
Report Number0001954182-2019-00036
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00514010100
Device LOT Number0028863
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 Received06/20/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/2018
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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