FDA Adverse Event Malfunction Summary report: N

PURELY YOURS

MDR report key: 5150410 · Received October 14, 2015

Report

Report Number: 3009974348-2015-00151
Event Type: Malfunction
Date Received: October 14, 2015
Date of Event: November 7, 2013
Report Date: November 7, 2013
Manufacturer: AMEDA, INC.
Product Code: HGX
PMA / PMN Number: K973501
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

UPON AMEDA ENGINEERING INVESTIGATION, A COMPONENT ON THE PRINTED CIRCUIT BOARD ASSEMBLY WAS FOUND TO BE DAMAGED. THE SMOKE, WHICH WAS OBSERVED BY THE USER, WAS GENERATED BY THE COMPONENT AS IT HEATED UP AND MELTED. THE MELTING OF THE INTEGRATED CIRCUIT'S (IC) RESIN HOUSING WOULD CAUSE SMOKING. NO OTHER DAMAGE ON THE PRINTED CIRCUIT BOARD ASSEMBLY OR WITHIN THE PUMP WAS OBSERVED. ULTIMATELY, IT WAS CONCLUDED THAT THE DEFECTIVE COMPONENT ON THE PRINTED CIRCUIT BOARD ASSEMBLY WAS DUE TO A MANUFACTURING DEFICIENCY. NO OTHER INCIDENTS HAVE BEEN REPORTED TO DATE, WHERE A COMPONENT HAS HEATED UP, MELTED, AND GENERATED SMOKE.

Description of Event or Problem · 1

AS PART OF AMEDA, INC.'S QUALITY MANAGEMENT SYSTEM ACTIVITIES, A REVIEW OF HISTORICAL COMPLAINTS WAS CONDUCTED. IT WAS DETERMINED THAT THIS COMPLAINT SHOULD HAVE BEEN REPORTED TO THE FDA. CUSTOMER CONTACTED AMEDA, INC. ON (B)(6) 2013 TO REPORT SMOKE COMING OUT OF THE PURELY YOURS BREAST PUMP FROM THE BATTERY COMPARTMENT DURING USE. THERE WERE NO BATTERIES IN THE COMPARTMENT AT THAT TIME. CUSTOMER WAS USING THE AC ADAPTER. CUSTOMER WAS INSTRUCTED NOT TO USE THE PUMP OR ADAPTER AND A REPLACEMENT WAS SENT TO HER THAT DAY. CUSTOMER STATES NO INJURY, BURN OR PROPERTY DAMAGE OCCURRED DURING THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
679018	PURELY YOURS	ELECTRIC BREAST PUMP	HGX	AMEDA, INC.	24502082

Patients

Seq	Age	Sex	Outcome	Treatment
1	29 YR