MAUDE Adverse Event Report: MEDELA LLC ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK); PUMP, BREAST, POWERED

Model Number 57018W

Device Problems Fire (1245); Melted (1385); Smoking (1585); Sparking (2595)

Patient Problem No Information (3190)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

Customer service requested that the product be returned for evaluation.Multiple attempts to contact the customer for additional information via email, phone,  and letter about the alleged incident went unanswered.The product involved in the  complaint was not returned for evaluation/investigation. therefore, no conclusions can be drawn at this time.The cause of the alleged fire with the pump in style breastpump cannot be determined at this time.

Event Description

The customer reported to medela customer service on (b)(6) 2017, that her pump in style advanced personal double breastpump had allegedly sparked, smoked, caught fire, and melted.

• Brand Name: ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK)
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; mchenry IL
• Manufacturer (Section G): MEDELA LLC; 1101 corporate drive; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6264479
• MDR Text Key: 65571815
• Report Number: 1419937-2017-00017
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57018W
• Device Catalogue Number: 57018W
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/09/2017
• Date Manufacturer Received: 01/09/2017
• 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