FDA Adverse Event Malfunction Summary report: N

PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE

MDR report key: 3834563 · Received March 19, 2014

Report

Report Number: 1419937-2014-00282
Event Type: Malfunction
Date Received: March 19, 2014
Date of Event: February 18, 2014
Report Date: February 18, 2014
Manufacturer: MEDELA, INC.
Product Code: HGX
PMA / PMN Number: K031614
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. UPON RECEIPT OF THE PRODUCT, A BREACH WAS FOUND IN THE TRANSFORMER. 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). A VISUAL EXAMINATION OF THE POWER SUPPLY REVEALED THE TRANSFORMER HOUSING WAS CRACKED OPEN, EXPOSING INNER ELECTRICAL CIRCUITRY. A VISUAL EXAMINATION OF THE CORD REVEALED NOTHING UNUSUAL. THE POWER SUPPLY WAS PLUGGED IN AND THE VOLTAGE ACROSS THE DC PLUG WAS MEASURED AT 13.60 VDC, WHICH IS NORMAL AND INDICATES THAT THE POWER SUPPLY IS PRODUCING THE CORRECT VOLTAGE. RESISTANCE ACROSS THE DC PLUG WAS MEASURED OPEN, WHICH INDICATES THAT THERE IS NOT A SHORT IN THE DC CORD. SMOKE, FIRE AND SPARKING WERE NOT OBSERVED WHILE THE POWER SUPPLY WAS PLUGGED IN. THE RESISTANCE ACROSS THE AC BLADES MEASURED AS 57.1 OHMS, WHICH IS NORMAL AND INDICATES THAT THE THERMAL FUSE DID NOT BLOW.

Description of Event or Problem · 1

CUSTOMER REPORTED TO CUSTOMER SERVICE THAT THE PRONGS ON THE TRANSFORMER OF HER PUMP IN STYLE PUMP WERE PUSHED INTO THE HOUSING; HOWEVER, WHEN THE PRODUCT WAS RECEIVED AND EVALUATED BY QE, A BREACH IN THE TRANSFORMER WAS FOUND EXPOSING UNDERLYING ELECTRONICS WHICH IS A SAFETY RISK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
163309	PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE		HGX	MEDELA, INC.	57063/9207010	1313/REV N

Patients

Seq	Age	Sex	Outcome	Treatment
1