MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - RFB; PUMP, INFUSION, ENTERAL

Model Number 382401

Device Problem Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2018

Event Type  malfunction  

Event Description

This unit was returned as back to stock and the customer didn't report a specific issue.Upon triage on (b)(6) 2018, the service tech found the unit had thermal damage on the c185 chip.

• Brand Name: KANGAROO EPUMP - RFB
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7788999
• MDR Text Key: 117296447
• Report Number: 1282497-2018-08017
• 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,Followup
• Report Date: 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 382401
• Device Catalogue Number: 382401
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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