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

Model Number 383401

Device Problems Thermal Decomposition of Device (1071); Failure to Power Up (1476)

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

Event Date 12/10/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 3/8/2017.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The unit was sent to a service center for repair.Upon triage, a technician found the unit would not on and the overlay was burnt.The unit has been repaired, firmware updated, tested and recertified per procedure.The unit was restored to proper operation.

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with an enteral feeding pump.The customer reports the unit will not power on.Upon triage, the technician found a burnt component.

• Brand Name: KANGAROO JOEY,PUMP W/CLMP,REFB
• 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: 6390010
• MDR Text Key: 69740923
• Report Number: 3006451981-2017-00201
• 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
• Report Date: 12/10/2016

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: Other
• Device Model Number: 383401
• Device Catalogue Number: 383401
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/10/2016
• Initial Date FDA Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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