MAUDE Adverse Event Report: COVIDIEN 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 08/14/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation: this complaint of a damaged power cord with exposed copper wires was investigated and confirmed.One sample was returned and consisted of u29525, scd 700 compression system, label: mfg date code 10-2013, [sn] (b)(4) power cord is damaged with exposed copper wires.The unit functions on ac power with a known good power cord connected.Unit functions on battery power as well.Root cause statement: customer damage/misuse.Ac power cord is damaged exposing copper wires.

Event Description

It was reported to covidien on (b)(6) 2015 that the customer stated had a damaged power cord.Upon triage on (b)(6) 2015 when the unit was returned to a local covidien service center a service technician found the unit had a damaged power cord with exposed copper wires.

• 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, 789 puxing road; shanghai ; CH
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5088502
• MDR Text Key: 26414360
• Report Number: 3006451981-2015-00212
• 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,user f
• Reporter Occupation: Other
• Report Date: 08/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2015
• 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
• Date Manufacturer Received: 08/25/2015
• 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