MAUDE Adverse Event Report: COVIDIEN SCD EXPRESS W/EXT HOOK; SCD CONTROLLER

Model Number 9525E

Device Problem Break (1069)

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

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 05/10/2016.An investigation is currently underway.Upon completion, a full detailed investigation will be provided.

Event Description

On (b)(6) 2016 the customer states the unit has a broken power cord.Upon triage on (b)(6) 2016 the service tech found the unit had a damaged power cord with exposed copper wires.

Manufacturer Narrative

A review of the information in the complaint file indicates this investigation was performed by a medtronic technical center for the reported condition of; a broken power cord.During triage a damaged power cord with exposed copper wire was found.Therefore, this report will be based on information provided by the technical center.The scd express was evaluated and the customer reported issue was confirmed; visual examination confirms damaged power cord with exposed copper wiring.The cause of the reported condition for the broken power cord is due to customer related accidental damage.The damaged power cord was scrapped and replaced to correct the reported issue.The unit passed all initial testing after failure analysis repair instructions were completed.Scd express was manufactured in 2011.A review of the device history record shows this device was released meeting all manufacturing specifications.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.Based on the investigation, no corrective action is needed.

• Brand Name: SCD EXPRESS W/EXT HOOK
• 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: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5644396
• MDR Text Key: 45223293
• Report Number: 3006451981-2016-00211
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9525E
• Device Catalogue Number: 9525E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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