• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010200
Device Problems Smoking; Electrical Shorting
Event Date 04/26/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Once the investigation is completed, a follow up/final report will be submitted.

 
Event Description

It was reported that the duo fluid cart began to smoke and there was an electrical fire. The event occurred after surgery. No adverse events were reported as a result of this malfunction.

 
Manufacturer Narrative

(b)(4). Other- device evaluated by authorized third part technician. The device history record (dhr) for intellicart system serial number (b)(4) was reviewed 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. On (b)(6) 2019, it was reported from (b)(6) medical center that the unit began to smoke and there was an electrical fire. 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 at the site and upon inspection of the unit found that there was no fire, or evidence that the unit had caused the smoke. The technician, and biomed at the site inspected the unit and found that both cylinders had been full of fluid when the surgeon was cauterizing during a case. The smoke from the process was being pulled into the cylinder, which had limited air space due to the amount of fluid. The limited space in the cylinder cause the smoke to leave the cart where possible, and appeared as an electrical issue to the account. Additionally, while inspecting the device the technician found that the ge filter was failing and replaced it with a buffalo filter (part #30041) 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. This complaint cannot be confirmed, as a technician was unable to duplicate or find evidence of the reported event upon inspection of the device. Additionally, for this reason a root cause cannot be selected for the reported event. The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.

 
Event Description

No additional information received.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDUO FLUID CART WITH SMOKE EVACUATOR
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 Key8570724
Report Number0001954182-2019-00030
Device Sequence Number1
Product CodeJCX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,USER F
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/01/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number00514010200
Device LOT Number0025615
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/15/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/24/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

-
-