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

Model Number	29525
Medical Device Problem Code	Cut In Material (2454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No specific issue was found in the service or complaint system for the return.Verified technician finding that the power cord was damaged and copper wiring was exposed.A pm/safety label on the front of the unit had the words "frayed cord" written over it in marker.Visual inspection of the cord found a cut in the outer insulation across the cord that had severed the internal black and white wires, exposing the inner copper.Power cord was removed and retained.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Upon triage, the technician found that the power cord was damaged and copper wiring was exposed.
Additional Manufacturer Narrative
One kendall scd 700 sequential compression system was received with no complaint listed.The unit was triaged and service found that the power cord was damaged exposing copper wires.Visual inspection of the cord found a cut in the outer insulation across the cord that had severed the internal black and white wires, exposing the inner copper.The power cord was replaced.The potential root cause is customer misuse by running over the cord with hospital bed or due to the procedure used to unplug the unit and the procedure of wrapping of the cord around the bed hook.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: 7564694
• Report Number: 3006451981-2018-00413
• Device Sequence Number: 1524377
• Product Code: JOW
• UDI-Device Identifier: 10884521129566
• UDI-Public: 10884521129566
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/07/2018

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 Expiration Date: 11/12/2013
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1