MAUDE Adverse Event Report: COVIDIEN SCD EXPRESS CONTROLLER; SCD PUMP

Model Number U9525

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

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

Event Type  malfunction  

Event Description

The customer reports non-specific issue.The unit was sent to a covidien service center.Upon triage, a service tech found the power cord is cut exposing bare copper wires.

Manufacturer Narrative

(b)(4) 2014.An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: SCD EXPRESS CONTROLLER
• Type of Device: SCD PUMP
• Manufacturer (Section D): COVIDIEN; 5920 longbow dr.; boulder CO 80301
• Manufacturer (Section G): COVIDIEN; 5920 longbow dr.; boulder CO 80301
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 3842586
• MDR Text Key: 4411980
• Report Number: 1717344-2014-00145
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/30/2014

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: U9525
• Device Catalogue Number: U9525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2014
• Initial Date FDA Received: 02/24/2014
• 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