FDA Adverse Event Malfunction Summary report: N

PUMP IN STYLE (ITEM # UNK)

MDR report key: 3820796 · Received April 14, 2014

Report

Report Number: 1419937-2014-00356
Event Type: Malfunction
Date Received: April 14, 2014
Date of Event: April 3, 2014
Report Date: April 7, 2014
Manufacturer: MEDELA, INC.
Product Code: HGX
PMA / PMN Number: K031614
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. ATTEMPTS TO CONTACT THE CUSTOMER ARE ONGOING. SHOULD ADDITIONAL INFORMATION OR THE ORIGINAL PRODUCT BE RECEIVED RESULTING IN NEW, CHANGED OR CORRECTED INFORMATION, A FOLLOW UP REPORT WILL BE FILED AT THIS TIME. THIS ISSUE WITH THE DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION (B)(4). THE INVESTIGATION FOUND THAT THE TRANSFORMERS ARE BEING DAMAGED DURING SHIPMENT FROM THE MANUFACTURER TO MEDELA. THIS DAMAGE IS CAUSING THE PLASTIC HOUSING TO FALL PREMATURELY WHEN SUBJECTED TO NORMAL USE AND FORESEEABLE MISUSE. THE PACKAGING USED BY THE MANUFACTURER TO SHIP THE TRANSFORMERS TO MEDELA IS NOT ROBUST ENOUGH TO HANDLE ALL OF THE POTENTIAL SHIPPING, HANDLING, AND ABUSE CONDITIONS THAT COULD ARISE FROM LOGISTICS OF THE CONSOLIDATION PROCESS. AS A RESULT OF THE INVESTIGATION, THE SHIPPING AND CONSOLIDATION PROCESS HAS BEEN MODIFIED TO REDUCE THE HANDLING AND POTENTIAL FOR DOUBLE STACKING OF THE SKIDS. THE SHIPPING PACKAGING STRENGTH HAS ALSO BEEN INCREASED TO FURTHER PROTECT THE TRANSFORMERS DURING SHIPPING.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE HOUSING FOR THEIR PUMP IN STYLE POWER SUPPLY OPENED UP ON ONE SIDE, WHICH IS A SAFETY ISSUE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
228175	PUMP IN STYLE (ITEM # UNK)		HGX	MEDELA, INC.	UNK/9207010	1511 / REV L

Patients

Seq	Age	Sex	Outcome	Treatment
1