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

Model Number 24502082

Device Problem Smoking (1585)

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

Event Date 04/15/2019

Event Type  malfunction  

Manufacturer Narrative

Pump would not power on with ameda lab supplied new duracell procell aa batteries due to the damaged series battery contact spring melting into the battery compartment wall where located.Damaged from a battery malfunction due to the misplacement of a battery or batteries in the battery compartment as well as leaving batteries in pump unit after pumping session can result in battery failure and or leakage, possibly causing damage to pump unit.

Event Description

Customer contacted ameda, inc.On (b)(6) 2019 to report smoke coming from the purely yours breast pump battery compartment as she pumped on (b)(6) 2019 using 6 new 7-11 aa batteries.She opened the battery compartment and the batteries were hot to touch.She touched them but states no burn/injury to her fingers.Customer states the batteries did not leak acid and they appeared undamaged.Mom later used the breast pump with the ac adapter but she detected a burning odor, so stopped using the breast pump.A replacement purely yours breast pump was overnight shipped 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: 8597464
• MDR Text Key: 144653316
• Report Number: 3009974348-2019-00340
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 0081072501477
• UDI-Public: (01)0081072501477(21)
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/29/2019
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2017
• 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: 33 YR