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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JABIL SINGAPORE KANGAROO JOEY, PUMP W/ POLE CLMP; FEEDING PUMP

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JABIL SINGAPORE KANGAROO JOEY, PUMP W/ POLE CLMP; FEEDING PUMP Back to Search Results
Model Number 383400
Device Problem Sparking (2595)
Patient Problem No Patient Involvement (2645)
Event Date 07/18/2014
Event Type  malfunction  
Event Description
It was reported to covidien on (b)(4) 2014 that a customer had an issue with a feeding pump.The customer states during testing, spark occurred from the plug and the battery could not be charged.No patient involvement.
 
Manufacturer Narrative
Submit date: (b)(4) 2014.An investigation is currently underway; upon completion, the results will be forwarded.
 
Manufacturer Narrative
A review of the device history records shows this device was released meeting all manufacturing specifications.During review of the unit, the reported condition by the customer was duplicated.The contact failure of the power cable was confirmed and replaced.There was no spark or burn mark confirmed on the unit.The gearbox cleaning was then performed.The connection of the power cable and the unit was loose and the connector was replaced.Based on the investigation no corrective and preventative action will be taken at this time.This complaint will be recorded for tracking and trending purposes.
 
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Brand Name
KANGAROO JOEY, PUMP W/ POLE CLMP
Type of Device
FEEDING PUMP
Manufacturer (Section D)
JABIL SINGAPORE
16 tampines industrial crescent
singapore 0000
SG  0000
Manufacturer (Section G)
JABIL SINGAPORE
16 tampines industrial crecsent
singapore
SN  
Manufacturer Contact
elaine bishop
15 hampshire street
mansfield, MA 02048
5084524686
MDR Report Key4041004
MDR Text Key17280660
Report Number3009247326-2014-00015
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeJA
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,Followup
Report Date 07/24/2014
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 Number383400
Device Catalogue Number383400
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/30/2014
Initial Date FDA Received08/05/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received09/30/2014
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 Number1
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