FDA Adverse Event Malfunction Summary report: N

SYMBIQ SINGLE CHANNE

MDR report key: 3894588 · Received May 21, 2014

Report

Report Number: 9615050-2014-03528
Event Type: Malfunction
Date Received: May 21, 2014
Date of Event: January 1, 2014
Report Date: April 21, 2014
Manufacturer: HOSPIRA COSTA RICA LTD.
Product Code: FRN
PMA / PMN Number: K110901
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: DE, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

A FIELD SERVICE ENGINEER PERFORMED TESTING AND INVESTIGATION AT THE USER FACILITY. DURING TESTING THE DEVICE ALARMED WITH A S233 MALFUNCTION ALARM CODE AND WAS NOTED IN THE DEVICE HISTORY. IT WAS NOTED THAT THE DEVICE FAN WAS NOT WORKING. THE PROBABLE CAUSE WAS DUE TO A BROKEN DEVICE COOLING FAN. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

Description of Event or Problem · 1

THE CUSTOMER CONTACT REPORTED THAT THE DEVICE ALARMED WITH A S233 (OVER TEMPERATURE ERROR) MALFUNCTION ALARM CODE. THE DEVICE WAS RETURNED TO THE BIOMEDICAL DEPARTMENT FOR AN UNSPECIFIED REASON. THERE WERE NO REPORTS OF ANY ADVERSE PATIENT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN USE. DURING TESTING AT THE USER FACILITY, THE DEVICE ALARMED WITH A S233 MALFUNCTION ALARM CODE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
303938	SYMBIQ SINGLE CHANNE	80FRN	FRN	HOSPIRA COSTA RICA LTD.	NA	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK