MAUDE Adverse Event Report: MEDELA INC PUMP PERSONAL DOUBLE; PUMP, BREAST, POWERED

Model Number 57038/9207010

Device Problems Break (1069); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

The customer was sent a replacement transformer.The product involved in the complaint was not returned for evaluation/investigation, and was disposed of by the customer.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 the 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

The customer reported to medela customer service on (b)(6) 2016, that the transformer prongs, for her pump in style advanced pump personal double, sparked while removing from the wall.Immediately following, the housing had fallen apart, exposing the inner circuitry, which is a safety risk.The customer disposed of the transformer.

• Brand Name: PUMP PERSONAL DOUBLE
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA INC; mchenry IL
• Manufacturer (Section G): MEDELA, INC.; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050 ; 8155782220
• MDR Report Key: 5468681
• MDR Text Key: 39584400
• Report Number: 1419937-2016-00060
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57038/9207010
• Device Catalogue Number: 57038/9207010
• Device Lot Number: REV M - 1512
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/08/2016
• Date Manufacturer Received: 02/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other