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

Device Problems Output Problem (3005); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 10/04/2021

Event Type  malfunction  

Event Description

Zimmer suction unit on opposite side of room creating vibrations on or table, keyboard on workstation, surgical mayo stand and back table.Unit is also extremely loud, making it difficult for circulator to hear surgeon and scrub requests.This case is a laparoscopic cholecystectomy, so this is not affecting patient care in this case; however, if this had been utilized in a case requiring a microscope, it would have been a potential patient safety issue.Cart utilized until end of case.

• Brand Name: INTELLICART¿
• 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: 12810630
• MDR Text Key: 280759636
• Report Number: 12810630
• 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: 11/04/2021

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14235 DA
• Patient Sex: Female