MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. A.T.S. 3000; TOURNIQUET, PNEUMATIC

Catalog Number 60-7070-157-00

Device Problems Deflation Problem (1149); Loss of Power (1475); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/20/2014

Event Type  malfunction  

Event Description

At the end of the procedure when the drapes were removed, the tourniquet was found to be still partially inflated on the left thigh.It had been turned off during the procedure.

• Brand Name: A.T.S. 3000
• Type of Device: TOURNIQUET, PNEUMATIC
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• MDR Report Key: 3775180
• MDR Text Key: 16683608
• Report Number: 3775180
• Device Sequence Number: 1
• Product Code: KCY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: 60-7070-157-00
• Device Lot Number: 2000000952
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2014
• Patient Sequence Number: 1
• Patient Age: 66 YR