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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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ZIMMER SURGICAL, INC. DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Model Number N/A
Device Problems Electrical /Electronic Property Problem (1198); Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2021
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded by zimmer biomet under (b)(4).Review of the most recent repair record determined the unit was not powering on when plugged into the wall.The power supply was replaced and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.The event is confirmed.
 
Event Description
It was reported a cart that would not power on from wall power.No other information was provided.The event timing was before surgery.The current repair record showed that the power supply had burn marks.No adverse event was reported as a result of this malfunction.
 
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Brand Name
DUO FLUID CART WITH SMOKE EVACUATOR AND POWER IV
Type of Device
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Manufacturer (Section D)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer (Section G)
ZIMMER SURGICAL, INC.
200 west ohio avenue
dover OH 44622
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key11900189
MDR Text Key253121924
Report Number0001526350-2021-00624
Device Sequence Number1
Product Code JCX
UDI-Device Identifier00889024501638
UDI-Public(01)00889024501638
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/27/2021
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 Number00514010400
Device Lot Number0042976
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/27/2021
Initial Date FDA Received05/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2020
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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