MAUDE Adverse Event Report: MEDELA, INC. PUMP IN STYLE (ITEM # UNK)

Model Number 57XXX/9207010

Device Problems Crack (1135); Protective Measures Problem (3015)

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

Event Date 03/24/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, the customer reported to medela customer svc that the transformer housing for pump in style advanced breast pump was cracked.The customer received a f/u call from the medela complaint handling unit.The customer informed the complaint coordinator that the transformer housing had been breached and was able to identify the inner electronic wiring.This is a safety risk.

Manufacturer Narrative

The customer was referred back to medela customer svc to obtain a replacement transformer.The product involved in the complaint was not returned for eval/investigation at this time.Therefore, no conclusions can be made as to the cause of the event.The cause of the breach in the rev n transformer has not been determined at this time.It is currently being investigated under (b)(4).

• Brand Name: PUMP IN STYLE (ITEM # UNK)
• Manufacturer (Section D): MEDELA, INC.; mchenry IL
• Manufacturer Contact: don alexander ; 1101 corporate dr.; mchenry, IL 60050 ; 8004358316
• MDR Report Key: 4723228
• MDR Text Key: 20720768
• Report Number: 1419937-2015-00119
• Device Sequence Number: 1
• Product Code: HGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 57XXX/9207010
• Device Catalogue Number: 57XXX/9207010
• Device Lot Number: REV N/1913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/07/2015
• Initial Date Manufacturer Received: 04/07/2014
• Initial Date FDA Received: 04/22/2015
• 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: Unknown
• Patient Sequence Number: 1