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

Model Number 29525

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

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/29/2015.This complaint of a damaged power cord with exposed copper wires was investigated and confirmed.One sample was returned and consisted of (b)(4), scd 700 compression system, label: mfg date code 03-2014, [sn] (b)(4).The power cord is damaged with exposed copper wires.The unit has functions on the ac power with a known good power cord connected.The unit functions on battery power.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 the customer initiated a service repair request regarding the unit having physical damage.Upon triage on (b)(6) 2015 the service tech found the unit had a damaged power cord with exposed copper wires.The unit was sent to the failure investigations department.

• 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: 5110272
• MDR Text Key: 27180533
• Report Number: 3006451981-2015-00226
• 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
• Reporter Occupation: Other
• Report Date: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• 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: 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