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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DORNOCH MEDICAL SYSTEMS, INC. ZIMMER BIOMET INTELLICART DUO; APPARATUS, SUCTION, WARD USE, PORTABLE, AC POWERED
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DORNOCH MEDICAL SYSTEMS, INC. ZIMMER BIOMET INTELLICART DUO; APPARATUS, SUCTION, WARD USE, PORTABLE, AC POWERED Back to Search Results
Model Number 00514010200
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problems Exposure to Body Fluids (1745); Fall (1848)
Event Date 05/29/2019
Event Type  malfunction  
Event Description
During the evacuation cycle, the base plate cracked, leaked onto the floor and results in a collection of surgical fluid/infectious waste.The puddle resulted in an employee injury (fall) and exposure to the infectious waste.When speaking with our service support tech, he commented that the base plate cracking is a commonly occurring issue with this "version" of the cart.The cart involved in the incident was a zimmer biomet (b)(4) intellicart duo model #00514010200, serial number (b)(4).It was removed from service and returned to mfr around 6/3.Fda product safety report id# (b)(4).
 
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Brand Name
ZIMMER BIOMET INTELLICART DUO
Type of Device
APPARATUS, SUCTION, WARD USE, PORTABLE, AC POWERED
Manufacturer (Section D)
DORNOCH MEDICAL SYSTEMS, INC.
MDR Report Key8727303
MDR Text Key149146993
Report NumberMW5087554
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number00514010200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2019
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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