inforMED

FLO LAB

Received Apr 22, 2010 · Event occurred Mar 26, 2010

Report 1679413 · MDR key 1679413

Device

Generic name

System, Ultrasound, Pulse Volume Recorder

Model number

2100SX FLO LAB

Catalog number

*

Lot number

*

Product problems

  • Electromagnetic Interference

Patient

*

  • No Information

Narrative

Description of Event or Problem

WE ARE TESTING VARIOUS LOCATION TRACKING TECHNOLOGIES (OFTEN REFERRED TO AS "RFID") FOR THE PAST FEW MONTHS IN RECOVERY ROOM AND BIOMED SHOP. THE GOAL IS TO ASSESS THE FEASIBILITY OF EMPLOYING ONE OR MORE OF THESE TECHNOLOGIES THROUGHOUT THE INSTITUTION.A TECHNICIAN AND A CLINICAL ENGINEER RECENTLY DISCOVERED THAT ONE OF THESE VENDOR'S TECHNOLOGIES, ONE THAT USES INFRARED (IR) AS THEIR PRIMARY LOCATING TECHNOLOGY, CAUSES INTERFERENCE WITH A MEDICAL DEVICE THAT HAS AN ACTIVE IR PORT, NAMELY A PULSE VOLUME RECORDER (PVR). WE HAVE BEEN ABLE TO DUPLICATE THE INTERFERENCE WITH THESE DEVICES AND ARE INVESTIGATING WHETHER OTHER MEDICAL DEVICES WITH ACTIVE IR PORTS MAY BE AFFECTED. THUS FAR NO OTHER DEVICES HAVE BEEN IDENTIFIED. (WE DO HAVE OTHER DEVICES WITH IR PORTS - BUT ON THOSE IDENTIFIED TO DATE THE PORTS ARE NOT ACTIVE WHEN IN CLINICAL USE). THE IR LOCATION SYSTEM (VENDOR: (B) (4)) HAS BEEN SHUT DOWN. THERE HAVE BEEN NO OCCURRENCES OF INTERFERENCE WITH A DEVICE IN CLINICAL USE. THE DISCOVERY WAS MADE IN OUR BIOMED SHOP WHILE A TECHNICIAN WAS TESTING THE PVR MACHINE.