MAUDE Adverse Event Report: COVIDIEN LP KANGAROO; PUMP, INFUSION, ENTERAL FEEDING

Model Number N/A

Device Problems Failure to Charge (1085); Failure to Power Up (1476); Device Displays Incorrect Message (2591)

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

Event Date 09/13/2017

Event Type  malfunction  

Event Description

Bio med reports continual issues with covidien enternal feeding pumps.Continue to receive error messages to plug it in when it is plugged in; will not power on, or will not keep a charge.

• Brand Name: KANGAROO
• Type of Device: PUMP, INFUSION, ENTERAL FEEDING
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 6921793
• MDR Text Key: 88437316
• Report Number: 6921793
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/19/2017,09/27/2017

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: Nurse
• Device Model Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1