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

Model Number 00-5140-103-00

Device Problem Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2021

Event Type  malfunction  

Event Description

Zimmer intellicart system duo fluid cart is extremely loud.

• Brand Name: INTELLICART
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.; 200 west ohio ave.; dover OH 44622
• MDR Report Key: 12391590
• MDR Text Key: 268974854
• Report Number: 12391590
• 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: 08/17/2021

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
• Device Catalogue Number: 00-5140-102-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA