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U.S. Department of Health and Human Services

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

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MEDELA INC. PUMP IN STYLE ADVANCED - ON-THE-GO TOTE; PUMP, BREAST, POWERED Back to Search Results
Model Number 9207010_57063
Device Problems Crack (1135); Scratched Material (3020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2016
Event Type  malfunction  
Manufacturer Narrative
A replacement power adapter was sent to the customer and requested the defective power adapter be returned for evaluation.The defective power adapter has not been received at medela as of 2/1/16.The product involved in the complaint was not returned for evaluation/investigation.Therefore, no conclusion can be made as to the cause of the event.Should additional information or the original product be received, resulting in new, changed, or corrected information, a follow up report will be filed at that time.This issue with a damaged transformer housing for the pump in style device was addressed in investigation (b)(4).The investigation found that the transformers 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 transformers to medela is 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 has been modified to reduce the handling and potential for double stacking of the skids.The shipping packaging strength has also been increased to further protect the transformers during shipping.Complaints against this product are currently being monitored for effectiveness of the above mentioned corrective action.
 
Event Description
On (b)(6) 2016, the customer contacted medela customer service stating that her pump in style transformer housing cracked, exposing inner electrical circuitry, which is a safety risk.
 
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Brand Name
PUMP IN STYLE ADVANCED - ON-THE-GO TOTE
Type of Device
PUMP, BREAST, POWERED
Manufacturer (Section D)
MEDELA INC.
1101 corporate dr
mchenry IL 60050
Manufacturer (Section G)
MEDELA INC.
1101 corporate dr
mchenry IL 60050
Manufacturer Contact
robert sokolowski
1101 corporate dr
mchenry, IL 60050
8155782220
MDR Report Key5408348
MDR Text Key37793117
Report Number1419937-2016-00019
Device Sequence Number1
Product Code HGX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 01/06/2016
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 Number9207010_57063
Device Catalogue Number9207010_57063
Device Lot NumberREV M - 1712
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/06/2016
Initial Date FDA Received02/03/2016
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 Unknown
Patient Sequence Number1
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