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

Model Number 24501649

Device Problem Sparking (2595)

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

Event Date 05/08/2017

Event Type  malfunction  

Manufacturer Narrative

The car adapter was received at ameda and evaluated for evidence of allegation of spark from car adapter.Allegation was not repeated as returned car adapter contained a defective fuse and therefore, it did not work.

Event Description

Customer contacted ameda, inc.To report a situation that occurred on (b)(6) 2017 while pumping in the car using her purely yours ultra breast pump and ameda car adapter.She states that in the middle of this pumping session, the car adapter began to spark causing a blown fuse in her new car.Customer describes the metal end of the car adapter broke off and the remainder of the adapter fell apart.She reports no injury in this event.

• Brand Name: PURELY YOURS ULTRA
• 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: 6638902
• MDR Text Key: 77623320
• Report Number: 3009974348-2017-00274
• Device Sequence Number: 1
• Product Code: HGX
• UDI-Device Identifier: 00810725021484
• UDI-Public: (01)00810725021484
• 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: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 24501649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2016
• 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: 40 YR