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U.S. Department of Health and Human Services

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

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SHANGHAI SCD 700 COMPRESSION SYSTEM-US; SCD CONTROLLER Back to Search Results
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.
 
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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 Key5091909
MDR Text Key26598814
Report Number3006451981-2015-00215
Device Sequence Number1
Product Code JOW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Model Number29525
Device Catalogue Number29525
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/21/2015
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 Number1
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