MAUDE Adverse Event Report: COVIDIEN KENDALL SCD; SLEEVE, LIMB, COMPRESSIBLE

Model Number	295251
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 6/5/17.An investigation is currently under way; upon completion the results will be forwarded.
Event or Problem Description
The customer reports: short circuit because of getting wet.During incoming inspection at the service center the following was found: power cord burnt and check valve leaking.
Additional Manufacturer Narrative
A review of the information in the complaint file indicates evaluation and repair was performed by a medtronic technical center, therefore, this report will be based on information provided by the technical center.The compression system scd 700, was found to have its power cord burnt as a result of arcing from liquid ingress on the wall plug end.The cause of the reported condition for the damaged power cord could be attributed to handling for the device within the hospital setting, allowing for exposure to a liquid at the plug end of the power cord while plugged into mains.The product ifu contains symbols to keep the device dry.The power cord was replaced by the service center to correct the reported issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KENDALL SCD
• Common Device Name: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 6610622
• Report Number: 3006451981-2017-05323
• Device Sequence Number: 13455520
• Product Code: JOW
• UDI-Device Identifier: 10884521129580
• UDI-Public: 10884521129580
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 295251
• Device Catalogue Number: 295251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1