FLO LAB
Received Apr 22, 2010 · Event occurred Mar 26, 2010
Report 1679413 · MDR key 1679413
Device
Generic name
System, Ultrasound, Pulse Volume Recorder
Manufacturer
Parks Medical ElectronicsModel number
2100SX FLO LABCatalog 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.