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

Model Number 57018W

Device Problems Component Falling (1105); Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

The customer was sent a replacement power supply.The customer returned the power adapter for evaluation.The product evaluation found the power supply housing to be breached.The issue with a damaged rev n power supply for the pump in style device was addressed in investigation (b)(4), which was trended as part of the effectiveness check for (b)(4), which found that the power supplies were being damaged during shipment from the manufacturer to medela.As a part of routine continuous improvement activities, the rev n power supply was replaced with a rev p power supply, manufactured under a revised design and by a different manufacturer.

Event Description

On (b)(6) 2017, the customer reported to medela llc that the power supply for her pump in style breast pump fell on the floor and parts of the housing cracked.

• Brand Name: ADVANCED PERSONAL DOUBLE BREASTPUMP (WITHOUT BATTERY PACK)
• 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: 7002667
• MDR Text Key: 92194478
• Report Number: 1419937-2017-00306
• 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: 11/04/2017

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: 57018W
• Device Catalogue Number: 57018W
• Device Lot Number: 9207010 REV N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2017
• Distributor Facility Aware Date: 10/31/2017
• Initial Date Manufacturer Received: 10/28/2017
• Initial Date FDA Received: 11/06/2017
• 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