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U.S. Department of Health and Human Services

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

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ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. DUO FLUID CART WITH POWER IV; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED Back to Search Results
Model Number 00-5140-103-00
Device Problems Vibration (1674); Noise, Audible (3273)
Patient Problem Insufficient Information (4580)
Event Date 06/17/2021
Event Type  malfunction  
Event Description
Zimmer intellicart extremely loud and vibrating the floor.Surgeon asked that the suction to be turned off and utilized the carousel suction device.Staff could not hear the name of specimen and could not hear report from surgical pathology report on frozen specimen.No harm to patient.Reported incident to perioperative nurse manager.
 
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Brand Name
DUO FLUID CART WITH POWER IV
Type of Device
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Manufacturer (Section D)
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
56 east bell drive
warsaw IN 46581
MDR Report Key12180191
MDR Text Key261923688
Report Number12180191
Device Sequence Number1
Product Code JCX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/02/2021
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 No Information
Device Model Number00-5140-103-00
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/02/2021
Event Location Hospital
Date Report to Manufacturer07/16/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age29565 DA
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