MAUDE Adverse Event Report: MEDELA LLC PUMP IN STYLE (UNKNOWN); PUMP, BREAST, POWERED

Model Number 9207010/UNKNOWN

Device Problems Material Separation (1562); Sparking (2595)

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

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

The product was received on 12/22/2016 and the product was evaluated by quality engineering on 2/1/2017 and during the evaluation is when medela became aware that the adapter was a prior to rev l.While the device did not test to specifications, no definitive conclusion regarding the cause of the reported event can be determined.The technician noted in the evaluation that there was exposed wires and the adapter is unsafe to plug in.

Event Description

The customer emailed customer service on (b)(6) 2016, stating her pump in style breast pump's power cord had exposed wires and sparks after she unplugs it.

• Brand Name: PUMP IN STYLE (UNKNOWN)
• Type of Device: PUMP, BREAST, POWERED
• Manufacturer (Section D): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer (Section G): MEDELA LLC; 1101 corporate dr; mchenry IL 60050
• Manufacturer Contact: robert sokolowski ; 1101 corporate drive; mchenry, IL 60050
• MDR Report Key: 6315981
• MDR Text Key: 67339535
• Report Number: 1419937-2017-00034
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9207010/UNKNOWN
• Device Catalogue Number: 9207010/UNKNOWN
• Device Lot Number: PRIOR TO REV L -16C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2016
• Distributor Facility Aware Date: 02/01/2017
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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