MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY,PUMP W/POLE CLMP; ENTERAL FEEDING PUMP

Model Number 383400

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer states blank display and lcd is cracked.

Manufacturer Narrative

Submit date: 03/30/2017.After further review of the initial reporter's event problem, it has been determined that a product malfunction did not occur.Therefore no additional investigation results will be sent.

Event Description

The customer states blank display and lcd is cracked.

• Brand Name: KANGAROO JOEY,PUMP W/POLE CLMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6342951
• MDR Text Key: 68107792
• Report Number: 1282497-2017-00234
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2017
• 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