FDA Adverse Event Malfunction Summary report: N

PUMP IN SYTLE ADVANCED BREAST PUMP GO TOTE

MDR report key: 3013185 · Received March 15, 2013

Report

Report Number: 1419937-2013-00150
Event Type: Malfunction
Date Received: March 15, 2013
Date of Event: February 22, 2013
Report Date: February 22, 2013
Manufacturer: MEDELA, INC.
Product Code: HGX
PMA / PMN Number: K031614
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

CUSTOMER FOLLOW-UP IS ONGOING. ATTEMPTS TO RETRIEVE THE PRODUCT AND ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE PRODUCT INVOLVED IN THE COMPLAINT HAS NOT BEEN RECEIVED FOR TESTING/ANALYSIS. WHILE NO CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF THE EVENT, THE TRANSFORMER HOUSING COMING APART AND THE SCREWS COMING OFF POSE A SAFETY RISK. ALTHOUGH THE PRODUCT HAS NOT BEEN EVALUATED, THIS TYPE OF FAILURE IS TYPICALLY ASSOCIATED WITH DROPPING THE UNIT ONTO A HARD SURFACE OR OTHER TYPE OF SEVERE IMPACT. THE ORIGINAL DESIGN TESTING INVOLVED DROPPING THE UNIT FROM A 1.0 M HEIGHT PER UL2601-1 SECOND EDITION. PRODUCTION SAMPLES WERE DROPPED THREE TO FIVE TIMES FROM A HEIGHT OF 1.0 M AND THE HOUSINGS SHOWED DAMAGE AND CRACKING (ONLY AFTER AT LEAST THREE DROPS). THIS PRODUCT WAS RELEASED AS A RESULT OF CAPA (B)(4), WHICH WAS INITIATED FOR PUMP IN STYLE TRANSFORMER OVERHEATING/MELTING ISSUES FOR WHICH A FIELD ACTION SAFETY NOTIFICATION WAS INITIATED ON 04/04/2011. COMPLAINTS AGAINST THIS PRODUCT ARE CURRENTLY BEING INVESTIGATED ((B)(4)) IN ORDER TO DETERMINE ROOT CAUSE AND WILL CONTINUE TO BE MONITORED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED A BREACH IN TRANSFORMER HOUSING. THE CUSTOMER STATED THE TRANSFORMER BROKE AND SCREWS CAME OUT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
110109	PUMP IN SYTLE ADVANCED BREAST PUMP GO TOTE		HGX	MEDELA, INC.	57063-9207010	UNK/REV

Patients

Seq	Age	Sex	Outcome	Treatment
1