MAUDE Adverse Event Report: MEDELA AG SYMPHONY; PUMP, BREAST, POWERED (SYMPHONY)

Model Number 0240309

Device Problems Circuit Failure (1089); Fire (1245)

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

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on 02/03/2021 and the possible cause for the short circuit is ingress of liquid between the power cord connector and the print (printed circuit board), which led to a short circuit.

Event Description

On 01/08/2021, medela (b)(4) was made aware of a user report made to (b)(6) regarding the symphony breast pump for an event which occurred on (b)(6) 2020.The user alleged the device was being used in parallel with a vacuum cleaner and it short circuited and had a cable fire.No injury reported.

• Brand Name: SYMPHONY
• Type of Device: PUMP, BREAST, POWERED (SYMPHONY)
• Manufacturer (Section D): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• Manufacturer (Section G): MEDELA AG; lattichstrasse 4b; baar zug, 6341 ; SZ 6341
• Manufacturer Contact: alea raber ; lattichstrasse 4b; baar zug, 6341 ; SZ
• MDR Report Key: 11274795
• MDR Text Key: 231244268
• Report Number: 3002807523-2021-00002
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K151632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0240309
• Device Catalogue Number: 0240309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2021
• Date Manufacturer Received: 01/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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