FDA Adverse Event Malfunction Summary report: N

PUMP IN STYLE ADVANCED - ON-THE-GO TOTE

MDR report key: 8418013 · Received March 13, 2019

Report

Report Number: 1419937-2019-00036
Event Type: Malfunction
Date Received: March 13, 2019
Date of Event: February 19, 2019
Manufacturer: MEDELA LLC
Product Code: HGX
UDI-DI: 00020451570631
PMA / PMN Number: K031614
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER AND RETURN OF HER ORIGINAL POWER SUPPLY WAS REQUESTED FOR TESTING/EVALUATION. IN FOLLOW UP WITH A COMPLAINT HANDLER ON (B)(6) 2019, THE CUSTOMER INDICATED THE POWER SUPPLY HOUSING CAME APART AND SMELLED LIKE FIRE WHEN SHE TRIED TO REMOVE IT FROM THE WALL OUTLET. ADDITIONALLY, SHE INDICATED THE BURN FROM TOUCHING THE HOT POWER SUPPLY DID NOT REQUIRE MEDICAL TREATMENT. 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.

Description of Event or Problem · 1

ON (B)(6) 2019, THE CUSTOMER ALLEGED TO MEDELA LLC THAT THE POWER SUPPLY FOR HER PUMP IN STYLE BREAST PUMP HAD AN ELECTRICAL SMOKE ODOR AND THE HOUSING HAD BROKEN APART. SHE ADDITIONALLY ALLEGED THAT THE POWER SUPPLY WAS HOT AND BURNED HER FINGER WHEN SHE TOUCHED IT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
210706	PUMP IN STYLE ADVANCED - ON-THE-GO TOTE	PUMP, BREAST, POWERED	HGX	MEDELA LLC	57063	9207010 REV N/2413	00020451570631

Patients

Seq	Age	Sex	Outcome	Treatment
1