MAUDE Adverse Event Report: COVIDIEN MFG PLAINFIELD

Model Number 383401

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The unit was sent to a service center for repair.Upon triage, a technician found that on the returned power cable there was a point on the cable where the internal wiring was exposed.The power source was replaced and the unit passed recertification without problems.The unit was restored to proper operation.

Event Description

It was reported to covidien on (b)(6) 2017 that an issue occurred with an enteral feeding pump.Upon triage on 06-apr-2017 the technician has found an exposed copper wire on the power cord.

• 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: 6543004
• MDR Text Key: 74498559
• Report Number: 3008361498-2017-05112
• Device Sequence Number: 1
• Product Code: LZH
• 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
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/16/2014
• Device Model Number: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2017
• Date Manufacturer Received: 04/06/2017
• 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: Initial
• Patient Sequence Number: 1