Description of Event or Problem · 1
THE PT HAS TO UNDERGO A 24 HOUR PH STUDY. THE PROBE WAS PLACED WITHOUT DIFFICULTY AND THE EXTERNAL MACHINE PROGRAMMED AND CALIBRATED CORRECTLY. NEW AA BATTERIES WERE INSTALLED. THE DEVICE WAS RECORDING WHEN THE PT LEFT THE HOSPITAL. WHEN THE PT RETURNED FOR ANALYSIS OF THE DATA, ONLY 15 MINUTES OF DATA HAD RECORDED. THE BATTERIES WERE PLACED INTO ANOTHER MACHINE AND THE MACHINE WOULDN'T TURN ON, READING "LOW VOLTAGE." NEW BATTERIES WERE PLACED IN THE MACHINE THAT HAD BEEN USED FOR THE PT, AND THE MACHINE FUNCTIONED WITHOUT DIFFICULTY. CLINICAL ENGINEERING EXAMINED THE MACHINE AND DETERMINED IT TO BE SAFE FOR USE. UNCLEAR AS TO IF THE BATTERIES DRAINED TOO QUICKLY OR WHETHER THE MACHINE MALFUNCTIONED. AT THIS TIME, UNSURE WHETHER REPEAT PROCEDURE WILL BE NECESSARY. PRODUCT IS AN OBSOLETE PRODUCT. RETENTION SAMPLES OF THIS DEVICE ARE NOT AVAILABLE. CUSTOMER DID NOT RETURN THE DEVICE (CONFIRMED THEY DO NOT EXPECT TO RETURN IT.) THEREFORE, THE INVESTIGATION IS LIMITED TO OTHER DEVICES OF THIS LOT IN THIS FIELD COMPLAINT RECORDS. FOUR ACCOUNTS RECEIVED DEVICES MADE WITH THIS WORK ORDER. ELEVEN RECORDERS WERE INCLUDED IN THESE 4 CUSTOMERS DEVICES. THIS IS THE ONLY EVENT IN THE COMPLAINT LOG SINCE THESE DEVICES WERE SHIPPED TO CUSTOMERS IN 2008. WE CONCLUDE THAT NO CORRECTIVE OR REMEDIAL ACTION OTHER THAN REPLACING BATTERIES IS REQUIRED. DEVICE IS: SLEUTH RECORDER, PART OF MII SYSTEM WITH 510K 012232.