MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

Model Number 57036/9207010

Device Problems Break (1069); Sparking (2595)

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

Event Date 10/16/2014

Event Type  malfunction  

Event Description

The customer reported that the power adapter for her pump in style breast pump started sparking at exposed wires by the housing, which is a safety risk.

Manufacturer Narrative

A replacement power supply was sent to the customer.A visual examination of the device was performed on 11/12/2014.The transformer performance was not evaluated as there are no corrective actions to implement.Medela has already changed to different transformers.There are no unacceptable risks from the risk analysis being caused by the incorrect output from the transformer that are not mitigated by features in the pump or warnings in the ifu.As a result of capa (b)(4) which was initiated for pump in style transformer overheating/melting issues, a field action safety notification was initiated on 04/04/2011.This device has been obsoleted.

• Brand Name: PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050-7005 ; 8004358316
• MDR Report Key: 4315078
• MDR Text Key: 5242137
• Report Number: 1419937-2014-00868
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: KI031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 57036/9207010
• Device Catalogue Number: 57036/9207010
• Device Lot Number: 16G/PRIOR TO REV L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/30/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/16/2014
• Date Manufacturer Received: 10/16/2014
• 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 Number: 1