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

Model Number	U9525
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports: system error.No patient involvement.Upon triage on (b)(6) 2017 it was noted by the service tech that there were exposed copper wires.
Additional Manufacturer Narrative
The scd express was evaluated and the review showed that the unit had a damaged power cord, with copper wire exposed.From the area in which the damage occurred it is possible this could be related to wear over time from the wrapping procedure of the cord around the bed hook.The cause of the reported condition for the damaged power cord was due to wear from potential wrapping technique overtime.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.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 MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 6763184
• Report Number: 3006451981-2017-05475
• Device Sequence Number: 13793226
• Product Code: JOW
• UDI-Device Identifier: 10884521100213
• UDI-Public: 10884521100213
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2017

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: U9525
• Device Catalogue Number: U9525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: 07/19/2017
• Supplement Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1