MalfunctionOBP

TRANSCRANIAL MAGNETIC STIMULATION MACHINE

Received Apr 19, 2019 · Event occurred Mar 27, 2019

Report MW5086032 · MDR key 8536049

Device

Generic name

Tms Machine / Transcranial/ Magnetic Stimulator

Manufacturer

Brainsway Ltd.

Model number

104

Product problems

Device Alarm System
Loss of Power

Patient

Not reported

No Information
No Information

Narrative

Description of Event or Problem

MCU ERRORS WHEN LOGGING OFF AND DURING TREATMENT; TECHS SAY IT IS A KNOWN CONTINUING ISSUE. ON (B)(6) 2019 AT 10:30 AM, MCU ERROR APPEARED WHEN ATTEMPTING TO LOG OFF MACHINE AFTER TREATMENT. ON (B)(6) 2019 AT 8:45 AM - MCU ERROR DURING PT'S TREATMENT. ONLY COMPLETED 17 MINS OF TREATMENT. ON (B)(6) 2019 AT 3:25 PM, MCU ERROR RIGHT BEFORE STARTING PT'S TREATMENT, WAS ABLE TO RESTART MACHINE AND HAVE UNINTERRUPTED TREATMENT. ON (B)(6) 2019, FIRST PT OF THE DAY - MACHINE SHUT DOWN 3 TIMES BEFORE STAYING ON LONG ENOUGH TO START TREATMENT.