MAUDE Adverse Event Report: SHANGHAI SCD 700 COMPRESSION SYSTEM-US; SCD CONTROLLER

Model Number 29525

Device Problems Break (1069); Thermal Decomposition of Device (1071); Failure to Power Up (1476)

Patient Problem No Information (3190)

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

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 was blinking but wouldn't turn on.Upon triage on 5/17/2016 the service tech found the unit had internal thermal damage at the control board and with burn marks on the inside of the front case.

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; unit was blinking but wouldn't turn on.During triage factory service found internal thermal damage at the control board and with burn marks on the inside of the front case.Therefore, this report will be based on information provided by the technical center.The 700 series scd was evaluated and the customer reported issue was confirmed; problem was isolated to destroyed components on the main bd.C62 was destroyed with its smoke trail rising up to the zip-tied wire bundle just under the handle, along with q7 which darkened u2 above it.The cause of the reported condition was due to component damage (c62, q7) on main bd.The main board was replaced to correct the reported issue.The unit passed all initial testing after failure analysis repair instructions were completed.The 700 series scd was manufactured in 2013.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 700 COMPRESSION SYSTEM-US
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): SHANGHAI; 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: 5660929
• MDR Text Key: 46574055
• Report Number: 3006451981-2016-00223
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/07/2016
• 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