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
The customer reports the pump has no power.Upon triage the service tech found the pump to have a physically burnt power supply.
Additional Manufacturer Narrative
Scd express controller was received for the unit with a complaint of ¿pump has no power.¿ the complaint was verified, as the power supply was burnt.The electrical power supply replaced and the tests of functionality and electrical safety have been validly valid in accordance with the manufacturer's instructions.The most probable root cause is the customer misuse due to the procedure used to unplug the unit and the procedure of wrapping of the cord around the bed hook.A review of the device history record shows that this unit was manufactured in 2016 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.

• 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: 7251338
• Report Number: 3006451981-2018-00093
• Device Sequence Number: 957628
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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: 01/24/2018
• Initial Date Received by Manufacturer: 01/26/2018
• Supplement Date Received by Manufacturer: 01/26/2018
• Initial Report FDA Received Date: 02/08/2018
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1