FDA Adverse Event Summary report: N

FLO LAB

MDR report key: 1679413 · Received April 22, 2010

Report

Report Number
1679413
Date Received
April 22, 2010
Date of Event
March 26, 2010
Report Date
April 9, 2010
Manufacturer
PARKS MEDICAL ELECTRONICS
Product Code
JAF
Report Source
User Facility report
Reporter Location
MA, US

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 FLO LAB SYSTEM, ULTRASOUND, PULSE VOLUME RECORDER JAF PARKS MEDICAL ELECTRONICS 2100SX FLO LAB *

Patients

Seq Age Sex Outcome Treatment
1 *