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

Model Number 295257

Device Problem Cut In Material (2454)

Patient Problem No Patient Involvement (2645)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports the cover of power cord was damaged.As a result of inspection in our local service center, copper wires were exposed.

Manufacturer Narrative

An evaluation of the scd 700 was performed for the reported condition of, ¿ power cord cover break (copper exposed) ¿.The unit was triaged and the reported issue was confirmed.As a result of inspection in our local service center, copper wires were exposed.The potential root cause is customer misuse due to the procedure used to unplug the unit and the procedure of wrapping of the cord around the bed hook.A 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.

• Brand Name: KENDALL SCD
• Type of Device: SLEEVE, LIMB, COMPRESSIBLE
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 7520039
• MDR Text Key: 108493016
• Report Number: 3006451981-2018-00362
• Device Sequence Number: 1
• Product Code: JOW
• UDI-Device Identifier: 10884521129603
• UDI-Public: 10884521129603
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

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
• Device Operator: Health Professional
• Device Model Number: 295257
• Device Catalogue Number: 295257
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 05/07/2018
• Supplement Dates FDA Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1