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

Model Number 29525

Device Problems Break (1069); Thermal Decomposition of Device (1071); Device Displays Incorrect Message (2591)

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

Event Date 03/20/2015

Event Type  malfunction  

Event Description

Customer states that the unit displays moisture build up.The unit was returned to a local covidien service center the service technician found that the control board is burnt and the front case was burnt and damaged.Several components are damaged due water getting inside the unit.

Manufacturer Narrative

An investigation is currently underway.Upon completion, an updated investigation will be provided.

Manufacturer Narrative

Submit date: 04/23/2015.An investigation of the reported condition was performed on (b)(4) 2015 by (b)(4).One scd 700 was returned for investigation for the reported condition of; service found: that the control board is burnt and several components are damaged due water getting inside the unit.The unit was tested in triage where it failed to meet operational specifications because the unit would not turn on ac power, confirming a failure within the unit.An internal inspection of the unit found that control board and front case are burnt and damaged due to fluid ingress, identifying the root cause of failure.There was no evidence of burn marks on the outside of the unit, indicating that the protective system functioned properly by containing the condition inside the unit.Therefore there was no risk of a hazardous condition to either the patient or the clinical staff.The control board and front case were replaced to correct the proble.Further inspection found that the lcd display, valve manifold, muffler, compressor, battery, and fan have water damage and were replaced to correct the problem.The unit was fully tested and passed all operational specifications.Product scd 700 compression system was manufactured in 2011.A review of the device history records shows this device was released meeting all manufacturing specifications.This information will be utilized for trending purposes to determine the need for corrective action.

• Brand Name: SCD 700 COMPRESSION SYSTEM-US
• Type of Device: SCD CONTROLLER
• Manufacturer (Section D): COVIDIEN; 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: 4698517
• MDR Text Key: 5715307
• Report Number: 3006451981-2015-00094
• 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
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• 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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2015
• 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