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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. INTELLICART; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

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ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC. INTELLICART; 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 08/27/2021
Event Type  malfunction  
Event Description
At the start of the surgical procedure, staff connected the suction tubing to the zimmer intellicart and activated the unit.The unit vibrated the floor and excessive noise.It was difficult to hear communication between surgeon, anesthesia, neuromonitoring staff throughout the procedure.
 
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Brand Name
INTELLICART
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 Key12452472
MDR Text Key270841627
Report Number12452472
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 08/31/2021
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
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/31/2021
Event Location Hospital
Date Report to Manufacturer09/10/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age27375 DA
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