FDA Adverse Event Malfunction Summary report: N

DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

MDR report key: 2832924 · Received November 15, 2012

Report

Report Number: 1226181-2012-00121
Event Type: Malfunction
Date Received: November 15, 2012
Date of Event: October 19, 2012
Report Date: October 19, 2012
Manufacturer: SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
Product Code: JJE
PMA / PMN Number: K051087
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: MEDICAL TECHNOLOGIST

Narratives

Additional Manufacturer Narrative · 1

A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE OF THE EVENT WAS AN UNSECURED EXHAUST TUBE MALFUNCTION. THE OPERATOR WAS NOT WEARING PROPER PERSONAL PROTECTIVE EQUIPMENT. THE OPERATOR'S GUIDE PROVIDES A WARNINGS: "FOLLOW STANDARD LABORATORY PROCEDURES FOR PROTECTION OF EYES AND SKIN FROM BIOHAZARDS AND CHEMICALS WHEN PERFORMING MAINTENANCE PROCEDURES." FURTHERMORE, "IT IS IMPORTANT TO FOLLOW STANDARD BIOHAZARD PROTECTION LABORATORY PRACTICE WHEN HANDLING THESE SPECIMENS OR WHEN OPERATING, MAINTAINING OR TROUBLESHOOTING THE INSTRUMENT." THE OPERATOR SECURED THE POPPED LINE ON THE INSTRUMENT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

Description of Event or Problem · 1

THE WATER PURIFICATION MODULE (WPM) EXHAUST TUBING POPPED OUT OF THE DRAIN AND SPRAYED THE OPERATOR. THE OPERATOR WENT TO THE EMERGENCY ROOM (ER) AND WAS ADMINISTERED FIRST AID. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THIS INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM	CLINICAL CHEMISTRY SYSTEM	JJE	SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW	VISTA 500

Patients

Seq	Age	Sex	Outcome	Treatment
1