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

Model Number 9525

Device Problems Thermal Decomposition of Device (1071); Charred (1086); Fire (1245)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to covidien on (b)(6) 2015 that the customer stated that an scd pump potentially initiated fire.The customer alleges that the power cord was charred/burned at the connection point on the scd machine and alleges no other source of fire was found.The customer alleges that the power cord on the machine was a non-standard power cord per the service repair letter.

Manufacturer Narrative

An investigation of scd express for the reported condition of; the customer alleges the scd express pump potentially initiated fire was performed on (b)(6) 2015.Customer alleges power cord was charred /burned at connection point on the scd machine and alleges no other source of fire was found.Customer alleges that the power cord on the machine was a non-standard power cord per a previous service repair.The scd express unit was evaluated and the customer reported issue was confirmed; the unit's power cord and receptacle were found with burn damage.The cause of the reported condition appears to have originated outside of the controller, likely at the interface of the power cord and the ac inlet connector.The cord used on the scd express was determined to be a non-standard power cord.The physical characteristics of the cord appear to be slightly different than the standard power cord.Precise measurements could not be made due the damage caused by fire but it is possible that the fit was impacted by the physical difference.No specific conclusion is drawn by the observations discussed here although the non-standard cord is believed to have been a primary factor in this instance.Scd express was manufactured in 2011.A review of the device history record shows this device was released meeting all manufacturing specifications.A corrective and preventative action has been referenced for this issue.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.

• Brand Name: SCD EXPRESS COMPRESSION SYSTEM
• 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: 5101726
• MDR Text Key: 26854776
• Report Number: 3006451981-2015-00216
• 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: Followup
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 9525
• Device Catalogue Number: 9525
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2015
• 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