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

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.

• 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 Key: 12180191
• MDR Text Key: 261923688
• Report Number: 12180191
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Number: 00-5140-103-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA