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

Model Number U6060

Device Problems Break (1069); Scratched Material (3020)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way, upon completion the result 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 reports a broken port.Upon triage, the service tech found a bad power cord that has copper wire exposed.

Manufacturer Narrative

Submit date: 03/15/2017.A review of the information in the complaint file indicates this investigation was performed by a medtronic technical center for the reported condition of; the unit had a power cord that has copper wire exposed.Therefore, this report will be based on information provided by the technical center.The avi controller was evaluated and the customer reported issue was confirmed.The copper is exposed on the cord and there are signs of cuts on the outer shielding.The cord was removed and scrapped.The unit passed all initial testing after failure analysis repair instructions were completed.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.Based on the investigation, no corrective action is needed.

• 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 blvd; plainfield IN 46168
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5996280
• MDR Text Key: 56807841
• Report Number: 3008361498-2016-00130
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• 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: AVI83672
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1