MAUDE Adverse Event Report: COVIDIEN SCD 700 COMPRESSION SYSTEM-US; SCD CONTROLLER

Model Number 29525

Device Problem Break (1069)

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

Event Date 07/23/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an non specific issue with an scd controller.When the unit was received at a local covidien service center the service technician found that the power cord was damaged, showing exposed copper wiring but there was no arcing.

Manufacturer Narrative

(b)(4).An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: SCD 700 COMPRESSION SYSTEM-US
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): COVIDIEN; building #10, 789 puxing; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building #10, 789 puxing rd; shanghai ; CH
• Manufacturer Contact: natasha soares ; 15 hampshire st; mansfield, MA 02048 ; 5084521608
• MDR Report Key: 4121900
• MDR Text Key: 4925395
• Report Number: 1717344-2014-00665
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/24/2014

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: Other
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2014
• Initial Date FDA Received: 07/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1