MAUDE Adverse Event Report: AMEDA., INC. MYA JOY; ELECTRIC BREAST PUMP

Model Number LD-306

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2022

Event Type  malfunction  

Manufacturer Narrative

Negative contact spring in battery compartment is damaged.Evidence supports that the contact spring was most likely damaged loading batteries into the battery compartment.Top level negative contact spring possibly made contact with lower level positive contact plate and battery while loading top battery into battery compartment.Four aa (1.5 volts max each) batteries required to operated the mya joy pump has six volts total load, was unable to recreate condition that resulted in the alleged spark event.Returned pump functions with ameda lab ac adapter and batteries.

Event Description

Customer contacted ameda, inc.On (b)(6) 2022 to report an event which occurred that morning as she was installing aa batteries into the battery compartment of her ameda mya joy breast pump.She reports attempting to place the second battery, which she states was very difficult to maneuver alongside the first battery, when sparks were emitted momentarily from the metal bracket where the top spring is located.Mom states seeing a light wisp of smoke and detected a burning odor.Customer denies any harm to herself or her baby.

• Brand Name: MYA JOY
• 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: 15565992
• MDR Text Key: 306784840
• Report Number: 3009974348-2022-00357
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172989
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LD-306
• Device Lot Number: 0920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White