MAUDE Adverse Event Report: COVIDIEN U6060 A-V IMPULSE CONTROLLER; FOOT PUMP

Model Number U6060

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/15/2016.An investigation is currently under way, upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a foot pump.The customer states low compressor opt.Upon triage on (b)(6) 2016 the service tech found the unit had a damaged power cord with exposed copper wire.

Manufacturer Narrative

Submit date: 10/10/2016.An investigation of av-impulse controller for the reported condition was performed for the reported condition of; exposed copper wire.The unit was triaged and the complaint was confirmed.The cause of the reported condition was due to rough handling.Power cords periodically require replacement due to age, usage and user damage.The service manual instructs the user to periodically inspect the power cords resistance to ensure its electrical safety.The unit was manufactured in 2008.A review of the device history record shows this device was released meeting all manufacturing specifications.

• Brand Name: U6060 A-V IMPULSE CONTROLLER
• Type of Device: FOOT PUMP
• Manufacturer (Section D): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer (Section G): COVIDIEN; 2824 airwest boulevard; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5953778
• MDR Text Key: 55259803
• Report Number: 3008361498-2016-00089
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: U6060
• Device Catalogue Number: U6060
• Device Lot Number: AVI80892
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1