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

Model Number MYA JOY PLUS

Device Problem Overheating of Device (1437)

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

Event Date 01/10/2023

Event Type  malfunction  

Manufacturer Narrative

The potential root cause of the damage on the mya joy plus pump power adapter type c plug may be excess "contact resistance" malfunction/failure due to contamination.Breast milk residue was found on the bottom of the pump base.The malfunction/failure did not impact or damage the returned power adapter base unit, returned mya joy plus pump's internal battery, or components on the mya joy plus circuit board inside the pump base.

Event Description

Customer contacted ameda, inc.On 01/11/2023 to report an event which occurred with her ameda breast pump.She reports plugging the mya joy plus into an electrical outlet in her kitchen to charge using the ameda usb charger.She used the same electrical outlet next to a bottle warmer, not in use.She went for a walk and when she returned in 45 minutes, she smelled an odor as though plastic was burning.Customer found the end of the usb ac adapter port had melted where it connects to the pump base.Mom states that 1-2 days prior to this event, the pump screen read error when she charged the pump and the charger felt warm to touch.Customer was not harmed in this event.A replacement mya joy plus breast pump with usb ac adapter was shipped overnight to the customer.

• Brand Name: MYA JOY PLUS
• Type of Device: ELECTRIC BREAST PUMP
• Manufacturer (Section D): AMEDA, INC.; 485 half day rd.; buffalo grove IL 60089
• Manufacturer Contact: linda zager ; 485 half day rd.; suite 320; buffalo grove, IL 60089 ; 8479642620
• MDR Report Key: 16308861
• MDR Text Key: 308960686
• Report Number: 3009974348-2023-00359
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203570
• 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: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MYA JOY PLUS
• Device Lot Number: 0920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Date Manufacturer Received: 01/11/2023
• 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: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White