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

Model Number 383400

Device Problems Crack (1135); No Display/Image (1183)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 02/17/2017.An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2017 that a customer had an issue with a feeding pump.The customer reports the unit has lcd issues.On (b)(6) service tech confirmed complaint.Upon further information from service tech as for this unit like most cracked lcds the display was black along the cracks and had very minimal sections of the screen that were legible i would say about 75-80% was blank.Once these liquid crystal displays break they don't really leave anything to be seen and because of the small size they are almost always blank.

Manufacturer Narrative

An evaluation of the kangaroo pump was performed for the reported condition of lcd issues.The unit was triaged and the reported issue was confirmed.The pump was excessively damaged, so the root cause is categorized as customer misuse.All device history records are reviewed for quality inspections and parameter compliance prior to releasing the product for shipment.Complaint trending information is being reviewed on a monthly basis and if a trend is observed, actions will be taken as necessary.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KANGAROO JOEY,PUMP W/POLE CLMP
• Type of Device: ENTERAL FEEDING PUMP
• Manufacturer (Section D): COVIDIEN; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer (Section G): COVIDIEN; 16 tampines industrial crecsent; singapore ; SN
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 04048 ; 5084524151
• MDR Report Key: 6360169
• MDR Text Key: 68608734
• Report Number: 1282497-2017-00230
• 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: 10/26/2017

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: Other
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Device Lot Number: F14051043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2016
• Initial Date FDA Received: 02/27/2017
• Supplement Dates Manufacturer Received: 12/13/2016
• Supplement Dates FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1