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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
Model Number N/A
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/30/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that there was smoke coming from the power inlet module while running prior to surgery.There was no patient or user involvement.Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it has been determined a zimmer biomet device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
 
Event Description
Upon receipt of additional information, it has been determined a zimmer biomet device did not cause or contribute to the reported event.The initial report was forwarded in error and should be voided.
 
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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 Key13059028
MDR Text Key282605832
Report Number0001954182-2021-00069
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/12/2022
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 Model NumberN/A
Device Catalogue Number00514010100
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/30/2021
Initial Date FDA Received12/22/2021
Supplement Dates Manufacturer Received12/24/2021
Supplement Dates FDA Received01/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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
Patient SexPrefer Not To Disclose
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