MAUDE Adverse Event Report: TYCO HEALTHCARE GROUP FEEDING PUMP

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 01/28/2018

Event Type  malfunction  

Event Description

Feeding pump displayed internal code error message upon setting up on 4 pumps.

• Brand Name: FEEDING PUMP
• Type of Device: FEEDING PUMP
• Manufacturer (Section D): TYCO HEALTHCARE GROUP; mansfield MA 02048
• MDR Report Key: 7233664
• MDR Text Key: 98881405
• Report Number: MW5074992
• Device Sequence Number: 3
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/30/2018
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 97