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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH ULTRA EVAC; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
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DORNOCH ULTRA EVAC; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Model Number N/A
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/21/2021
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Once the investigation is completed, a follow-up/final report will be submitted.Evaluated third party.
 
Event Description
It was reported that during cleaning the unit was found leaking.
 
Event Description
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.
 
Manufacturer Narrative
Upon receipt of additional information, it has been determined that this device did not cause or contribute to a serious injury or a reportable malfunction.The initial report was forwarded in error and should be voided.
 
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Brand Name
ULTRA EVAC
Type of Device
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Manufacturer (Section D)
DORNOCH
200 northwest parkway
riverside MO 64150
MDR Report Key11712553
MDR Text Key249618880
Report Number0001954182-2021-00019
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
PMA/PMN Number
K133786
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 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberUL-EV100
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
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