FDA Adverse Event Death Summary report: N

SPACELABS ULTRAVIEW PT MONITOR

MDR report key: 3931266 · Received June 20, 2014

Report

Report Number: 3010157426-2014-00015
Event Type: Death
Date Received: June 20, 2014
Date of Event: January 30, 2014
Report Date: March 2, 2014
Manufacturer: SPACELABS HEALTHCARE INC.
Product Code: MHX
PMA / PMN Number: K102422
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ID, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER STATED THAT THE TELEMETRY WAS NOT READING CONSISTENTLY. A SPACELABS FIELD SERVICE ENGINEER (FSE) INVESTIGATED IN THE DEVICE ONSITE AND CONFIRMED ALL FUNCTIONAL TESTS PASSED. FROM THE FULL DISCLOSURE DATA PROVIDED BY THE CUSTOMER, WE OBSERVED THAT FROM 3:45 AM, ONLY ONE LEAD (LEAD I) WAS AVAILABLE FOR MONITORING THE SAME PT. AT 4:17 AM LEAD I CAME OFF THE PT, RESULTING IN A MEDIUM PRIORITY LEADS-OFF ALARM LASTING UNTIL 5:27 AM. AT 5:27 AM LEAD I WAS REPLACED ON THE PT AS ECG WAVEFORM RETURNED. THE MONITOR IMMEDIATELY ALARMED FOR ASYSTOLE, WITH THE SAME LASTING UNTIL 5:38 AM. THE ALARM RECORDS IN THE FULL DISCLOSURE DATABASE INCLUDED THAT THE DEVICE IDENTIFIED THE LEADS OFF CONDITION AND ALARMS WERE GENERATED FOR THIS CONDITION. WHEN THE ELECTRODE WAS REATTACHED, THE PT WAS IN ASYSTOLE AND APPROPRIATE ALARMS WERE GENERATED FOR ASYSTOLE. WE HAVE CONCLUDED THAT THE DEVICES WERE OPERATING IN SPECIFICATIONS AND CONSIDER THIS ISSUE CLOSED.

Description of Event or Problem · 1

SPACELABS RECEIVED AN INCIDENT REPORT THAT A PT PASSED AWAY ON (B)(6) 2014 WHILE A SPACELABS TELEMETRY MONITOR WAS IN USE ON THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
364050	SPACELABS ULTRAVIEW PT MONITOR	MHX: MULTIPARAMETER PT MONITOR	MHX	SPACELABS HEALTHCARE INC.	91387

Patients

Seq	Age	Sex	Outcome	Treatment
1				90343, SN (B)(4)