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

Model Number	295251
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the device had has arcing damage on the mains lead and the inlet connector.
Additional Manufacturer Narrative
An evaluation of the scd 700 was performed and the customer states ¿the device had arcing damage on the mains lead and the inlet connector.¿ the unit was triaged, and the customer¿s reported condition was confirmed.The potential root causes are excessive damage due to customer misuse.Device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.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 monthly 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: 6994226
• Report Number: 3006451981-2017-05725
• Device Sequence Number: 1005734
• Product Code: JOW
• UDI-Device Identifier: 10884521129580
• UDI-Public: 10884521129580
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 11/20/2017

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: 295251
• Device Catalogue Number: 295251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1