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

Model Number	95258
Medical Device Problem Code	Cut In Material (2454)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/11/2018
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 reports the pump has a damaged power cord with exposed copper wires.
Additional Manufacturer Narrative
An evaluation of the scd express was performed and the customer states ¿pump has a damaged power cord with exposed copper wires.¿ the unit was triaged and the customer¿s reported condition was confirmed and the cable has no earth pin.The unit was triaged and the customer¿s reported condition was confirmed.The pump was excessively damaged, so the root cause is categorized as 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.

• 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: 7463882
• Report Number: 3006451981-2018-00308
• Device Sequence Number: 1544348
• Product Code: JOW
• UDI-Device Identifier: 10884521082755
• UDI-Public: 10884521082755
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2018

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: 11/26/2022
• Device Model Number: 95258
• Device Catalogue Number: 95258
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1