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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 Device Emits Odor (1425)
Patient Problem No Patient Involvement (2645)
Event Date 08/14/2019
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Udi #: (b)(4).On (b)(6) 2019, it was reported from (b)(6) medical center that an intellicart unit would not power on the monitor.The previous work order in customer relationship management (crm) 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 work order noted no issues with the device after repair and all verifications, inspections and tests were successfully completed.On (b)(6) 2019, it was reported from (b)(6) medical center that an intellicart unit would not power on the monitor.On 14 august 2019, c3 tech, llc was contacted about the cart and dispatched a service technician to be at the site.The technician arrived at the site and confirmed power issues, noting that the cart would not power on when plugged into an outlet.He also noted a clicking noise and burning smell/ the technician replaced the power inlet module (part #90204) and the appropriate fuses (part #90562) 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.Service work order (b)(4) on 14 august 2019.The root cause for the unit not powering on was due to a failed power inlet module.The power inlet module is where the ac power cable plugs into the unit and also houses the fuses for the cart.The module failing would prevent the cart from getting power, and the unit would not turn on at all.The reported event was confirmed during inspection of the device and the device was noted to be functioning as intended after the power inlet module and its fuses were replaced.The investigation was based on the information that was provided initially and any information that was obtained throughout the follow-up process.Based on the information provided, this investigation determined that there is no need for further action (ie/capa/scar/hhe/d) at this time.This complaint will be tracked and trended per complaint trending procedure for any adverse trends that may require additional actions.
 
Event Description
It was reported that the unit would not power on the monitor.The event timing was before surgery.The investigation revealed the unit had a burning smell.No adverse events were reported as a result of this malfunction.
 
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Brand Name
DUO FLUID CART
Type of Device
APPARATUS, 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 Key8945099
MDR Text Key207034429
Report Number0001954182-2019-00053
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number00514010100
Device Lot Number0024178
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/29/2019
Initial Date FDA Received08/29/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2016
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
Patient Sequence Number1
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