MAUDE Adverse Event Report: COVIDIEN, FORMERLY KENDALL, A DIVISION OF TYCO HEALTHCARE SCD 700 COMPRESSION SYSTEM; SLEEVE, LIMB, COMPRESSIBLE

Model Number 700 SERIES

Device Problems Cut In Material (2454); Scratched Material (3020)

Patient Problem No Information (3190)

Event Date 05/07/2014

Event Type  malfunction  

Event Description

This unit has a cover that secures the power cord to the back of the unit.This cover has a sharp edge that rubs the power cords to the point where the insulation breaks down and wires are exposed.These are replaced during routine maintenance and we are experiencing a very high rate of failure.

• Brand Name: SCD 700 COMPRESSION SYSTEM
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN, FORMERLY KENDALL, A DIVISION OF TYCO HEALTHCARE; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 4322348
• MDR Text Key: 5206829
• Report Number: 4322348
• Device Sequence Number: 1
• Product Code: JOW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/07/2014

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
• Device Operator: Invalid Data
• Device Model Number: 700 SERIES
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2014
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1