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

Lot Number 11210310

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) hospital (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) hospital (b)(6) 2022 intellicart serial number (b)(4) ¿ cart shut down when vacuum turned on, vendor called in, found power inlet module had failed, showed signs of overheating and replaced the module (b)(6) hospital (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 displayed a melted component, replaced the module.Fda safety report id # (b)(4).

• Brand Name: ZIMMER WASTE DISPOSAL UNIT
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ZIMMER BIOMET INTELLICART / ZIMMER SURGICAL, INC.; lexington KY
• MDR Report Key: 13928605
• MDR Text Key: 288172089
• Report Number: MW5108523
• Device Sequence Number: 3
• 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: Other
• Type of Report: Initial
• Report Date: 03/23/2022
• 3 Devices were Involved in the Event: 1 2 3

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 Lot Number: 11210310
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1