PROPAQ CORDLESS
Received Oct 30, 1996 · Event occurred Oct 1, 1996
Report 3023750-1996-00003 · MDR key 47077
Device
Generic name
Telemetry Transmitter
Manufacturer
Protocol Systems, Inc.Model number
NACatalog number
900-0093-00
Lot number
UNK
Patient
UNKNOWN
Narrative
Description of Event or Problem
THE MFR WAS TELEPHONED ON 10/2/96 BY A USER FACILITY AND INFORMED THAT ONE PT HAD BEEN MIS-MEDICATED AS THE RESULT OF A USER ERROR OF ONE OF THE DEVICES MADE BY MFR. USER FACILITY REPORTED THAT NO PT INJURY RESULTED FROM THE MIS-MEDICATION. ACCORDING TO THE USAER FACILITY, A STAFF MEMBER APPLIED A TELEMETRY TRANSMITTER TO A PT AND FAILED TO FOLLOW PROCEDURE TO VERIFY THE CORRECT FREQUENCY AND ID NUMBER ACCORDING TO DEVICE LABELING. THIS ERROR RESULTED IN ONE PT'S ECG DATA BECOMING TEMPORARILY CONFUSED WITH THAT OF ANOTHER NEARBY PT. THE ERROR WAS CORRECTED BY THE USER FACILITY STAFF. FREQUENCY OF EVENT STATEMENT: THIS IS THE FIRST INSTANCE OF A CUSTOMER COMPLAINT OF THIS KIND REPORTED TO MFR. SEVERITY OF EVENT STATEMENT: MFR IS UNAWARE OF ANY RATING OR CLASSIFICATION SCALE IN WHICH TO RANK OR QUANTIFY THE SEVERITY OF A USER ERROR EVENT OF THIS KIND.