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

Model Number	U9525
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
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 customer states a damaged power cord.Upon triage service technicians found the wires to be exposing copper.No patient involved or harmed.
Additional Manufacturer Narrative
An evaluation of the kendall express scd system was preformed for the reported condition of, ¿ a damaged power cord¿.The unit was triaged and the customer¿s reported condition was confirmed and the power cord was found to have exposed copper wire.After a visual inspection of the unit under testing, the power cord was observed to be severed with exposed copper wire.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; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7508461
• Report Number: 3006451981-2018-00351
• Device Sequence Number: 19195755
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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 Model Number: U9525
• Device Catalogue Number: U9525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1