MAUDE Adverse Event Report: COVIDIEN SCD RESPONSE; SCD CONTROLLER

Model Number 73267

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

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

Event Date 05/28/2014

Event Type  malfunction  

Event Description

The customer states that prior to use on a pt, the covering of power cable was broken.No pt involvement.The unit was sent to a covidien service center for repair.Upon triage, a service tech found exposed copper wires on the power cord.

Manufacturer Narrative

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

• Brand Name: SCD RESPONSE
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): COVIDIEN; 5920 longbow dr.; boulder CO 80301
• Manufacturer (Section G): COVIDIEN; 5920 longbow dr.; boulder CO 80301
• Manufacturer Contact: amy anderson ; 15 hampshire st.; mansfield, MA 02048 ; 5084524644
• MDR Report Key: 3906436
• MDR Text Key: 20106240
• Report Number: 1717344-2014-00491
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 73267
• Device Catalogue Number: 73267
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/29/2014
• 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