MAUDE Adverse Event Report: AMEDA, INC. PURELY YOURS; ELECTRIC BREAST PUMP

Model Number 24502082

Device Problem Sparking (2595)

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

Event Date 04/18/2017

Event Type  malfunction  

Manufacturer Narrative

Engineering investigation notes: after evaluating the power adapter that was returned from the user as well as the picture supplied by the user, the spark occurred due to a short between the two ac leads of the power adapter.The charring occurs when a media exists and burns due to the high current shorting the two leads.This type of failure is typical when the two leads are shorted together or when some kind of media exists between the two leads and a connection occurs.Overall, this type of failure is common with any device that connects to a wall outlet.The failure is consistent with some type of conductive media (i.E.Milk, water, etc) shorts across the two ac leads.The level of risk is consistent across any wall connected device.

Event Description

Customer contacted ameda, inc.On (b)(6) 2017 to report an incident that occurred the day before, on (b)(6) 2017 while pumping with the purely yours breast pump at work.She had completed a pumping, went to remove the ac adapter from the electrical socket and sparks were emitted from the adapter, frightening but not harming her.Customer noted a charred area on the ac adapter near the prongs.A replacement ac adapter was shipped overnight to the customer.

• Brand Name: PURELY YOURS
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA, INC.; 485 half day rd.; suite 320; buffalo grove IL 60089
• Manufacturer Contact: linda zager ; 485 half day rd.; suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 6577035
• MDR Text Key: 75527576
• Report Number: 3009974348-2017-00265
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973501
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24502082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2016
• 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 Age: 37 YR