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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED
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MEDELA LLC BREASTPUMP PNSA STARTER; PUMP, BREAST, POWERED Back to Search Results
Model Number 57081
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/26/2018
Event Type  malfunction  
Manufacturer Narrative
A replacement power supply was sent to the customer.The issue with a damaged rev p power supply for the pump in style device is currently being evaluated under an investigation for complaint category (b)(4).A conclusion regarding this issue cannot be made at this time.
 
Event Description
On (b)(6) 2018, the customer alleged to medela (b)(4) that the housing on the power supply for her pump in style breast pump cracked when she went to plug it in.
 
Manufacturer Narrative
The power supply was returned and evaluated on 03/19/2018 and during the evaluation it was identified that the revision on the power supply was initially reported as rev p, but was determined in the evaluation to be rev l.This medwatch filing is to correct the revision of the power supply.This issue with a damaged rev l power supply for the pump in style device was addressed in investigation (b)(4).The investigation found that they were being damaged during shipment from the manufacturer to medela.This damage was 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 increased to further protect the power supply during shipping.Since then, as a part of routine continuous improvement activities, a rev p power supply has been distributed to market, manufactured under a revised design and by a different manufacturer.
 
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Brand Name
BREASTPUMP PNSA STARTER
Type of Device
PUMP, BREAST, POWERED
Manufacturer (Section D)
MEDELA LLC
1101 corporate dr
mchenry IL 60050
MDR Report Key7319782
MDR Text Key101858691
Report Number1419937-2018-00072
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
Type of Report Initial,Followup
Report Date 03/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number57081
Device Catalogue Number57081
Device Lot Number9207010/REV L/1211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2018
Distributor Facility Aware Date02/26/2018
Date Manufacturer Received03/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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