MAUDE Adverse Event Report: COVIDIEN SCD EXPRESS COMPRESSION SYSTEM; SCD CONTROLLER

Model Number 9525

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/04/2014

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Submit date: 08/18/2014.An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: SCD EXPRESS COMPRESSION SYSTEM
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): COVIDIEN; building #10, 789 puxing; changhai ; CH
• Manufacturer (Section G): COVIDIEN; building 10 789 puxing road; shanghai ; CH
• Manufacturer Contact: natasha soares ; 15 hampshire street; mansfield, MA 02048 ; 5084521608
• MDR Report Key: 4218700
• MDR Text Key: 4976097
• Report Number: 3006451981-2014-00707
• 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: 08/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9525
• Device Catalogue Number: 9525
• Device Lot Number: SN1021332
• 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