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

Model Number 29525

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

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

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/21/2015 investigation: the complaint of 'the unit had a damaged case, a broken screen, and an issue with the cord coming out.Service tech found the unit had a damaged power cord with exposed copper wires' was investigated and issue was confirmed.One sample was returned and consisted of 29525, scd 700 compression system-us, label: [ref] (b)(4), mfg date code 05-2014, (b)(4).Confirmed complaint that the power cord is cut off.Although the power cord wall plug has a slightly bent ground prong, it would still plug in to a wall outlet and function normally and not affect retention.The display screen has a visible impact dent on the right side.See photo attached.When unit was turned on, the display's lower half is illegible due to impact.As power cord was damaged, connected to leg sleeve (a), powered on under internal battery only, and unit starts normally (software revision ) but display is damaged due to impact and the lower half of the screen is illegible.Battery status indicators 1-3 are green green green indicating battery state of 67-100% charge.The damaged power cord will be scrapped by fi.Substituted fi power cord, connected to ac battery status indicators 1-3 are green green green(pulsing) indicating battery state of 67-99% charge and unit continues to function normally.Turned off/on and unit functions normally.Root cause statement: both the damaged power cord and display are customer related and not manufacturing nor service related.

Event Description

It was reported to covidien on (b)(6) 2015 that the customer stated the unit had a damaged case, a broken screen, and an issue with the cord coming out.The unit was returned to a local covidien service center and during 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): SHANGHAI; 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: 5091909
• MDR Text Key: 26598814
• Report Number: 3006451981-2015-00215
• 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: 09/03/2015

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?: No
• Device Operator: Other
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/03/2015
• 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