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

The customer reports the pump has been sent in for back to stock.Upon triage the service tech found the power cord to be damaged and have exposed copper wires.

Manufacturer Narrative

An evaluation of the scd express was performed and the unit was triaged, the service tech found the power cord to be damaged and have exposed copper wires.Strands of copper wires poked out through the wire insulator and another insulator appears half melted due to heat from the exposed copper wire of the power cord.Upon receipt, the pump has a bed hook and power cord.The power cord bundle insulator was ripped open.The unit could not be powered up with the damaged power cord for safety reasons due to the nature of the type of damage.The potential root causes are customer misuse 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: 7187782
• MDR Text Key: 97374665
• Report Number: 3008361498-2018-00021
• 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: 01/22/2018

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: 01/12/2018
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/12/2018
• Supplement Dates FDA Received: 01/22/2018
• 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