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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED

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MEDELA LLC PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED Back to Search Results
Model Number 57063/9207010
Device Problem Crack (1135)
Patient Problem No Information (3190)
Event Date 06/13/2017
Event Type  malfunction  
Manufacturer Narrative
A replacement power supply was sent to the customer.The product was received and an evaluation confirmed that the power supply housing was breached.This issue with a damaged rev m power supply for the pump in style device was addressed in investigation (b)(4).The investigation found that they are being damaged during shipment from the manufacturer to medela.This damage is causing the plastic housing to fail prematurely when subjected to normal use and foreseeable misuse.The packaging used by the manufacturer to ship the power supply to medela was not robust enough to handle all of the potential shipping, handling, and abuse conditions that could arise from logistics of the consolidation process.As a result of the investigation, the shipping and consolidation process was modified to reduce the handling and potential for double stacking of the skids.The shipping packaging strength was also been increased to further protect the power supply during shipping.Complaints against this product are currently being monitored for effectiveness of the above mentioned corrective action.
 
Event Description
On (b)(6)2017, the customer alleged to customer service that the power supply for her pump in style advanced breast pump housing cracked and she put electrical tape on it.
 
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Brand Name
PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
Type of Device
PUMP, BREAST, POWERED
Manufacturer (Section D)
MEDELA LLC
1101 corporate dr
mchenry IL 60050
Manufacturer (Section G)
MEDELA LLC
1101 corporate drive
mchenry IL 60050
Manufacturer Contact
robert sokolowski
1101 corporate drive
mchenry, IL 60050
MDR Report Key6696432
MDR Text Key79928564
Report Number1419937-2017-00189
Device Sequence Number1
Product Code HGX
Combination Product (y/n)N
PMA/PMN Number
K031614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 07/10/2017
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 Lay User/Patient
Device Model Number57063/9207010
Device Catalogue Number57063/9207010
Device Lot NumberREV M / 1212
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2017
Distributor Facility Aware Date06/13/2017
Initial Date Manufacturer Received 06/13/2017
Initial Date FDA Received07/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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