M300 - BEUDAMED

Report

Report Number: 1220063-2013-00003
Event Type: Death
Date Received: January 24, 2013
Date of Event: January 8, 2013
Report Date: January 8, 2013
Manufacturer: DRAEGER MEDICAL SYSTEMS, INC.
Product Code: MHX
PMA / PMN Number: UNK
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

INFINITY M300 AND INFINITY CENTRAL STATION (ICS) LOGS WERE PROVIDED TO DRAEGER FOR ANALYSIS. BASED ON THE INFO PROVIDED, NO DEVICE MALFUNCTION WAS FOUND. THE LOGS DID NOT INDICATE ANY TECHNICAL PROBLEMS OR NETWORK ISSUES AT THE TIME OF THE EVENT. THE ROOT CAUSE FOR THE REPORTED ISSUE IS THAT THE M300 DEVICE WAS IN STANDBY AT THE TIME OF THE EVENT. WHILE IN STANDBY, NO ALARMS OR WAVEFORMS WERE STORED AT THE ICS PER DESIGN. DRAEGER ASSESSED THE RISK FOR THE REPORTED ISSUE AND DETERMINED THAT THERE ARE NO NEW OR REVISED RISKS. NO ACTIONS ARE PLANNED BY DRAEGER AT THIS TIME. DRAEGER WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS OF THIS ISSUE.

Description of Event or Problem · 1

IT WAS REPORTED THAT AS OF 4:30 AM ON (B)(6) 2013, M300 DEVICE DATA WAS NO LONGER SHOWN AT THE INFINITY CENTRAL STATION (ICS). THE OFFLINE STATUS WAS NOT DISPLAYED NOR WAS ANY ALARM AT THE ICS TRIGGERED. AROUND 5:30 AM, THE NIGHT NURSE WENT TO CHECK ON THE PT, WHO WAS VERY RESTLESS. IT WAS ALSO REPORTED THAT THE NURSE ASKED ABOUT THE HANDLING OF THE M300 IN THE INTENSIVE CARE UNIT (ICU) BY TELEPHONE BECAUSE SHE WAS NOT YET FAMILIAR WITH THE MONITORING SYSTEM. IT WAS REPORTED THAT AT ABOUT 6:40 AM, THE PT WAS FOUND DEAD. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
34781	M300	PATIENT MONITOR	MHX	DRAEGER MEDICAL SYSTEMS, INC.	MS25755	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Death	NO