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

Model Number	29525
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Information (3190)
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 that the unit has a display issue.Upon triage it was noted that the power cord has exposed copper wires.
Additional Manufacturer Narrative
An evaluation of the scd 700 compression system was performed for the reported condition of, ¿the unit has a display issue¿.The unit was triaged and service found that the power cord had exposed copper wires.It was verified the power cord was damaged and copper wire was exposed.Root cause of failure could not be determined.The power cord was twisted and had the green, white, and black insulated wires exposed.The black wire (line) was completely severed with copper wire exposed and frayed.The green and white wires were intact.Power cords periodically require replacement due to age, usage and user damage.In other similar complaints, kinking of the cable assembly along the cord length, which is indicative of being tightly wrapped around the bed hook has been identified as a contributing factor for this failure mode.Over time, tightly wrapping of the cord in this fashion causes a constant tension to be applied to the outer cover resulting in the cover being milked out of the strain relief.Stretching the power cord at a sharp angle to the plug to reach the wall outlet has the same effect.Therefore the potential root cause for this issue is customer misuse.A ll 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: 7674294
• Report Number: 3006451981-2018-00501
• Device Sequence Number: 920227
• Product Code: JOW
• UDI-Device Identifier: 10884521129566
• UDI-Public: 10884521129566
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/03/2018

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: 10/18/2024
• Device Model Number: 29525
• Device Catalogue Number: 29525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 07/09/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/06/2018; 10/03/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1