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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

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DORNOCH DUO FLUID CART WITH SMOKE EVACUATOR; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Catalog Number 00514010200
Device Problem Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/20/2020
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once an investigation of the device is completed, a follow-up/final report will be submitted.
 
Event Description
It has been reported that the cart was smoking from the back.The event timing was prior to surgery.There was no harm to the patient and no delay.No adverse events were reported as a result of this malfunction.
 
Manufacturer Narrative
This event has been recorded by zimmer biomet under: (b)(4).This medwatch is being filed to relay additional information.The following sections were updated: date of report, udi #, concomitant medical products, pma/510k, if follow-up, what type, device evaluated by mfr, device manufacture date, usage of device.Udi #: (b)(4) product review of the duo fluid cart w/ smoke evac (00514010200) serial number: (b)(4) by a zimmer biomet certified service repair technician on 24 february 2020 revealed that the power inlet module had failed.However, there were no signs of the unit smoking as all wires on the united looked in good working order.The power inlet module was replaced.The technician also found the vacuum pump was an older style so it was proactively replaced.The unit was tested and returned to service.Repair of the device was performed by a zimmer biomet certified service repair technician on 24 february 2020 which included replacement of the following: intellicart power supply (part#: 70097 and lot code#: 0041385).Additional repair included proactively replacing the intellicart vacuum pump capacitor (part#: 70216 and lot code#: 0042731).The device, serial number: (b)(4), was then tested and functioned properly.It was repaired, inspected and tested.The duo fluid cart w/ smoke evac (00514010200) serial number: (b)(4) has been previously repaired/evaluated 2 times as documented in the repair reports in crm.The last repair was 8 march 2019 by a zimmer biomet certified service repair technician where it was reported that the unit was not draining properly.The technician removed a plastic foreign object from cylinder #1.The unit was tested and returned to service.This is not a related issue.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Device is used for treatment.The root cause of the reported issue is attributed to a malfunctioning power inlet module.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.
 
Event Description
No additional event information.
 
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Brand Name
DUO FLUID CART WITH SMOKE EVACUATOR
Type of Device
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Manufacturer (Section D)
DORNOCH
200 northwest parkway
riverside MO 64150
MDR Report Key9764929
MDR Text Key181199275
Report Number0001954182-2020-00013
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
PMA/PMN Number
K162421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 04/22/2020
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 Number00514010200
Device Lot Number0025687
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/20/2020
Initial Date FDA Received02/27/2020
Supplement Dates Manufacturer Received04/21/2020
Supplement Dates FDA Received04/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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