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

Model Number 29525

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

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

Event Date 10/21/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/27/2015.An investigation is currently underway.Upon completion, a full detailed investigation will be provided.

Event Description

On (b)(6) 2015 the customer initiated a service repair request regarding a ripped power cord.Upon triage on (b)(6) 2015 the service tech found the unit had a damaged power cord with exposed copper wires.

Manufacturer Narrative

An investigation of scd 700 compression system for the reported condition was performed on (b)(6) 201515 by (b)(6).A review of the information in the complaint file indicates this investigation was performed by a covidien/medtronic technical center for the reported condition of; damaged power cord.Therefore, this report will be based on information provided by the service center.The unit was triaged and the complaint was confirmed; power cord is damaged with exposed copper wire.The root cause of the power cord failure can be attributed to rough handling.Power cords periodically require replacement due to age, usage and user damage.The power cord was replaced to correct the problem.The unit was then fully tested.Scd 700 compression system was manufactured in 2015.A review of the device history record shows this device was released meeting all manufacturing specifications.

• 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: 5181900
• MDR Text Key: 30048181
• Report Number: 3006451981-2015-00256
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• 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
• Device Lot Number: V1509095SX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/21/2015
• 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