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

Model Number 383400

Device Problem No Audible Alarm (1019)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The customer stated that the unit failed to alarm when tubing is off rotor wheel.

• Brand Name: KANGAROO JOEY,PUMP W/POLE CLMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7869090
• MDR Text Key: 119974657
• Report Number: 1282497-2018-08052
• 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: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 383400
• Device Catalogue Number: 383400
• Date Manufacturer Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1