MAUDE Adverse Event Report: ZIMMER BIOMET INTELLICART / ZIMMER SURGICAL, INC. ZIMMER BIOMET INTELLICART WASTE DISPOSAL UNIT; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Device Problems Overheating of Device (1437); Failure to Power Up (1476); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

(b)(6) 2022 intellicart serial number (b)(4) - cart would not power on, vendor called in, found power inlet module had failed, showed signs of overheating and replaced the module (b)(6) 2022 intellicart serial number (b)(4) - cart would not power on, power inlet module was discolored and showed signs of overheating, vendor called in, verified power inlet module had failed and replaced the module.Fda safety report id # (b)(4).

• Brand Name: ZIMMER BIOMET INTELLICART WASTE DISPOSAL UNIT
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ZIMMER BIOMET INTELLICART / ZIMMER SURGICAL, INC.
• MDR Report Key: 13928580
• MDR Text Key: 288171265
• Report Number: MW5108522
• Device Sequence Number: 1
• Product Code: JCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 03/23/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1