MAUDE Adverse Event Report: SHANGHAI SCD EXPRESS COMPRESSION SYSTEM; SCD CONTROLLER

Model Number 9525

Device Problems Break (1069); Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Event Description

The customer did not note a specific issue.Upon triage a service technician confirmed a broken power cord with exposed copper wires.

Manufacturer Narrative

Submit date: (b)(4) 2015.An investigation of the reported condition was performed on (b)(6) 2015 by (b)(6).One scd 700 was returned for investigation for the reported condition of; the customer did not note a specific issue.Upon triage a service technician confirmed a broken power cord with exposed copper wires.An initial inspection of the power cord found it failed to meet operational specifications due to damage, which cut through to the inner wires, exposing them, confirming the reported condition.Power cords periodically require replacement due to age, usage and user damage.The service manual instructs the user to periodically inspect the power cords resistance to ensure its electrical safety.The power cord was replaced to correct the problem.The unit was then fully tested and found to function normally and within specifications.Product scd 700 was manufactured in 2010.A review of the device history records shows this device was released meeting all manufacturing specifications.A review of the service history records indicates there are no other service histories recorded for this system.This information will be utilized for trending purposes to determine the need for corrective action.

Manufacturer Narrative

(b)(4).An investigation is currently underway.Upon completion, an updated investigation will be provided.

Manufacturer Narrative

The original date of the 3500a report indicated (b)(6) 2015 which was incorrect at the time of the initial submission.The correct date is (b)(6) 2015.Both date of this report and date received by manufacturer have been corrected.As a result of the incorrect date on the initial submission which was on (b)(6) 2015, the 3500a form was filed late, over the 30 day requirement.However, based on the correct notification date, the complaint was actually filed within the 30 day requirement.

• Brand Name: SCD EXPRESS COMPRESSION SYSTEM
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): SHANGHAI; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building #10, puxing road; shanghai ; CH
• Manufacturer Contact: amy anderson ; 15 hampshire street; mansfield, MA 02048 ; 5084524644
• MDR Report Key: 4732980
• MDR Text Key: 5742620
• Report Number: 3006451981-2015-00106
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9525
• Device Catalogue Number: 9525
• Device Lot Number: SN1006980
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2015
• 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