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 Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The unit was returned and upon triage it was noted that there are signs of thermal damage.
Additional Manufacturer Narrative
An evaluation of the scd express controller was performed for the reported condition of, "unknown¿.The unit was triaged and service found that there are signs of thermal damage.The unit was received without a battery and the unit was disassembled.Inspection found thermal damage on the power supply pcba.The pcba was found to be burned where the daughter card acn standoff meets the main power supply pcba.Further inspection found signs of damage and slight liquid ingress on the rear housing.Power supply liquid ingress resulted in minor to moderate pooling on the power board, and is the result of customer misuse.The liquid pooling on the power board likely corroded and weakened the solder connections where the daughter board standoffs are located.The weakened solder connections could have resulted in arcing or burning at that location which could have further led to other component damage or burning on the power board.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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7669480
• Report Number: 3006451981-2018-00497
• Device Sequence Number: 789592
• Product Code: JOW
• UDI-Device Identifier: 10884521100213
• UDI-Public: 10884521100213
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 05/05/2013
• Device Model Number: U9525
• Device Catalogue Number: U9525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 07/05/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/03/2018; 10/03/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1