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 08/18/2022

Event Type  malfunction  

Manufacturer Narrative

Returned mya joy ac adapter was not tested citing safety concerns.Damage to the 120-volt transformer housing, prongs and their connection to the pcb indicates that the returned ac adapter most likely sustained damage prior to spark event.Ameda was unable to determine the fault of the 120-volt transformer housing and missing prong damage.

Event Description

Customer contacted ameda, inc.On (b)(6) 2022 to report sparking from the mya joy power adapter as she plugged it into an outlet at work on (b)(6) 2022.She immediately pulled out the adapter from the outlet by grasping the black plastic housing which then broke apart.One of the two prongs fell out.Customer denied injury to herself.Customer was overnight shipped a replacement mya joy power adapter.

• 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: 15428059
• MDR Text Key: 305419368
• Report Number: 3009974348-2022-00356
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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: 09/06/2022
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White