FDA Adverse Event Malfunction Summary report: N

LCD TOUCHSCREEN, RP150, S5

MDR report key: 2587635 · Received May 14, 2012

Report

Report Number: 1718850-2012-00269
Event Type: Malfunction
Date Received: May 14, 2012
Date of Event: February 22, 2011
Report Date: April 30, 2012
Manufacturer: SORIN GROUP DEUTSCHLAND
Product Code: DTQ
PMA / PMN Number: K071318
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

SORIN GROUP (B)(4) MANUFACTURES THE LCD TOUCHSCREEN. THE LCD TOUCHSCREEN IS A COMPONENT OF THE S5 ROLLER PUMP. THE 510(K) NUMBER FOR THE S5 ROLLER PUMP IS K071318. THE INCIDENT OCCURRED IN (B)(6). THIS MDR REPORT IS BEING SUBMITTED ON BEHALF OF THE DEVICE MFR - SORIN GROUP (B)(4). AS COMMITTED TO FDA'S OFFICE OF COMPLIANCE, A RETROSPECTIVE REVIEW OF CUSTOMER COMPLAINTS IS BEING PERFORMED AND MDRS WILL BE SUBMITTED IN ACCORDANCE WITH THE REVISED PROCEDURE. THIS MDR IS BEING SUBMITTED BEYOND THE 30 DAY REPORTING REQUIREMENT AS IT WAS IDENTIFIED DURING THE RETROSPECTIVE REVIEW. THE UNRESPONSIVE TOUCH SCREEN OBSERVED BY THE USER WAS DUE TO A LOSS OF ELECTRICAL CONTACT AT THE CABLE CONNECTION. FIELD ACTIONS WERE IMPLEMENTED TO ADDRESS THIS SPECIFIC ISSUE (REFERENCE FDA RECALL NUMBERS Z-0956-2011 THROUGH Z-0965-2011 AND Z-1149-2012 THROUGH Z-1158-2012). TO DATE THERE HAVE BEEN NO REPORTED INJURIES AS A RESULT OF THIS ISSUE. NO FURTHER ACTION IS DEEMED NECESSARY.

Description of Event or Problem · 1

SORIN GROUP REC'D A REPORT THAT THE TOUCH SCREEN WOULD NOT RESPOND. THERE WAS NO REPORT OF PT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LCD TOUCHSCREEN, RP150, S5	CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS	DTQ	SORIN GROUP DEUTSCHLAND	97-103-616	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1