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

Model Number 29525

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/21/2015.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 05-2011, [sn] (b)(4).The 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.Root cause statement: customer damage/misuse.Ac power cord is damaged exposing copper wires damaged power cord was scrapped in fi.Recommend to replace power cord and process per standard fs procedures.

Event Description

It was reported to covidien on 9/11/2015 the customer initiated a service repair request but did not state a specific issue.The unit was returned to a local covidien service center and upon triage on (b)(6) 2015 the service tech 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 ; 5084524811
• MDR Report Key: 5091390
• MDR Text Key: 26598708
• Report Number: 3006451981-2015-00213
• 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: 09/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• 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: 09/18/2015
• 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