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

Model Number INTELLICART SUCTION SYSTEM

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Suction Problem (2170); Defective Component (2292); Reset Problem (3019)

Patient Problem Insufficient Information (4580)

Event Date 03/03/2022

Event Type  Injury  

Event Description

Various incidents with zimmer intellicart system: suction clogs ¿ frequent clogs and many needing technical service/intervention to clear.Resetting power, power supply failures, fuses blown, found loose solder in fuse box as well.Disappearance of control icons from intellicart screens, suction sensor failures requiring service.Patient safety issue, conflicting readings on amount of fluid recovered between digital readout and manual canister reading.Depending on if cases are only one canister use (use canister reading) or if stacking multiple cases per canister, use digital reading.Spills and leaks, despite the design to alarm and alert when canister is full; too loud during cases.Therapy is still ongoing; still using since we have no replacement yet.Fda safety report id # (b)(4).

• Brand Name: INTELLICART
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): ZIMMER SURGICAL, INC.
• MDR Report Key: 13797190
• MDR Text Key: 287400887
• Report Number: MW5108204
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INTELLICART SUCTION SYSTEM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention