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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JABIL SINGAPORE KANGAROO EPUMP - INTERNATIONAL; FEEDING PUMP
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JABIL SINGAPORE KANGAROO EPUMP - INTERNATIONAL; FEEDING PUMP Back to Search Results
Model Number 482400S
Device Problems Break (1069); Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 01/24/2014
Event Type  malfunction  
Event Description
It was reported to covidien on (b)(6) 2014 that a customer had an issue with a kangaroo epump.The customer reports that the unit was found with damage to the battery, battery leads and battery compartment.The damage appears to be from an electrical failure.The unit was found in this condition on the dieticians desk.No other information available and no patient involved.
 
Manufacturer Narrative
An investigation is currently underway, upon completion the results will be forwarded.
 
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Brand Name
KANGAROO EPUMP - INTERNATIONAL
Type of Device
FEEDING PUMP
Manufacturer (Section D)
JABIL SINGAPORE
16 tampines industrial crescent
singapore
SN 
Manufacturer (Section G)
JABIL SINGAPORE
16 tampines industrial crescent
singapore
SN  
Manufacturer Contact
elaine bishop
15 hampshire st.
mansfield, MA 02048
5084524686
MDR Report Key3717274
MDR Text Key4247464
Report Number3009247326-2014-00001
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number482400S
Device Catalogue Number482400S
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received01/24/2014
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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