FDA Adverse Event Summary report: N

INTELLIVUE

MDR report key: 1960036 · Received December 29, 2010

Report

Report Number: 1960036
Date Received: December 29, 2010
Date of Event: December 23, 2010
Report Date: December 29, 2010
Manufacturer: PHILIPS MEDICAL SYSTEMS
Product Code: DRG
Report Source: User Facility report
Reporter Location: MI, US

Narratives

Description of Event or Problem · 1

AT APPROXIMATELY 19:41 HOURS THE PATIENT MONITORING FOR A SINGLE PATIENT WAS LOST DUE TO A SUSPECTED SIGNAL LOSS.SYSTEM LOGS WERE RAN AND DID NOT INDICATE ANY ERRORS WITHIN THE WIRELESS NETWORK. NURSING STAFF CONFIRMED THAT A "NO SIGNAL" ALARM WAS RECEIVED AT THE PHILIPS INFORMATION CENTER (PIC).THE PATIENT WAVE REVIEW SHOWS NO MONITORING DATA (ECG WAVE FORMS) FOR THIS PATIENT FOR 39 MINUTES.HEALTH PROFESSIONAL'S IMPRESSION: NO CARDIAC MONITORING FOR A SINGLE PATIENT FOR 39 MINUTES.MANUFACTURER RESPONSE FOR TRANSMITTER, PHYSIOLOGICAL, TELEMETRY:MFG. IS SCHEDULING RESOURCES TO VISIT SITE AND GATHER DATA TO FURTHER ASSIST WITH THE INVESTIGATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTELLIVUE	TRANSMITTER, PHYSIOLOGICAL, TELEMETRY	DRG	PHILIPS MEDICAL SYSTEMS	M4841A	*
2	INTELLIVUE	MONITOR, PHYSIOLOGICAL, CENTRAL, TELEMETRY	MHX	PHILIPS MEDICAL SYSTEMS	M3155	*

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR			NO OTHER THERAPIES