MAUDE Adverse Event Report: COVIDIEN KANGAROO EPUMP - INTERNATIONAL; ENTERAL FEEDING PUMP

Model Number 482400S

Device Problem Sparking (2595)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with enteral feeding pump.The customer reports the transformer sparks.

• Brand Name: KANGAROO EPUMP - INTERNATIONAL
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer (Section G): COVIDIEN; building # 10, 789 puxing road; shanghai ; CH
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6075509
• MDR Text Key: 59132951
• Report Number: 3006451981-2016-00556
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 482400S
• Device Catalogue Number: 482400S
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/01/2016
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1