MAUDE Adverse Event Report: COVIDIEN MFG PLAINFIELD KENDALL SCD; SLEEVE, LIMB, COMPRESSIBLE

Model Number U9525E

Device Problem Cut In Material (2454)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Upon triage, it was discovered that the power cord was damaged and exposed copper was found.

Manufacturer Narrative

One kendall scd express sequential compression system was received for failure analysis.The reported symptom was verified.Upon visual inspection of the unit, the power cord was observed to be damaged with exposed copper wire.The root cause of the reported symptom was misuse/handling due to the procedure used to unplug the unit and the procedure of wrapping of the cord around the bed hook.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 MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN MFG PLAINFIELD; 2824 airwest blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7309315
• MDR Text Key: 101372732
• Report Number: 3008361498-2018-00123
• Device Sequence Number: 1
• Product Code: JOW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

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: U9525E
• Device Catalogue Number: U9525E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 03/02/2018
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1