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

Model Number 29525

Device Problems Break (1069); Scratched Material (3020)

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

Event Date 08/04/2014

Event Type  malfunction  

Event Description

The customer reported a non-specific issue to covidien on (b)(6) 2014.The unit was returned to a local covidien service center and the service tech found that the power cord was damaged with exposed copper wirin but there was no arcing.

Manufacturer Narrative

Submit date: 08/14/2014.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 road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building 10 789 puxing road; shanghai ; CH
• Manufacturer Contact: natasha ; 5 hampshire st.; mansfield, MA 02048-0000 ; 5084521608
• MDR Report Key: 4059605
• MDR Text Key: 18571853
• Report Number: 3006451981-2014-00704
• 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: Unknown
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2014
• 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