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

Model Number	295250
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
Upon triage the service center found the pump to have a damaged power cord had burning.
Additional Manufacturer Narrative
An evaluation of the scd 700 compression system was performed and upon triage, service found the unit had a power cord with thermal damage.The unit was cleaned and disinfected in accordance with the manufacturer's instructions.It was noted that the plug was burnt.The power cord was replace and the device has been tested according to the manufacturer's specifications.All the tests have been successfully completed.Power cords periodically require replacement due to age, usage and user damage.The service manual instructs the user to periodically inspect the power cord¿s resistance to ensure its electrical safety.If they are not replaced, normal flexing, wrapping the cord too tightly around the bed hook, or supporting the weight of the unit with the cord can cause individual wire strands to break, which increases the amount of heat generated by current flow; over time the continued flexing of the cord results in melting of the wire insulation and catastrophic failure.Therefore the potential root cause for this issue is customer misuse.A review of the device history record shows that this unit was manufactured and was released meeting all manufacturing specifications.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.

• 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: 7646073
• Report Number: 3006451981-2018-00486
• Device Sequence Number: 122067
• Product Code: JOW
• UDI-Device Identifier: 10884521129573
• UDI-Public: 10884521129573
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 295250
• Device Catalogue Number: 295250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 05/15/2018; 08/08/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/25/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1