MAUDE Adverse Event Report: COVIDIEN SCD EXPRESS COMP SYSTEM JAPAN; SCD CONTROLLER

Catalog Number 95257

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2014

Event Type  malfunction  

Event Description

It was reported to covidien on (b)(6) 2014 that the customer had an issue with an scd controller.The customer states that during use on a pt the power code was found damaged.There was no pt harm.

Manufacturer Narrative

Submit date on 08/11/2014.An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: SCD EXPRESS COMP SYSTEM JAPAN
• 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 soares ; 15 hampshire street; mansfield, MA 02048 ; 5084521608
• MDR Report Key: 4073311
• MDR Text Key: 4739383
• Report Number: 3006451981-2014-00699
• 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: Unknown
• Type of Report: Initial
• Report Date: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 95257
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2014
• 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