INTELECT MOBILE 2CH STIM INT'L STD
Received Dec 6, 2018 · Event occurred Nov 19, 2018
Report 9616086-2018-00025 · MDR key 8139663
Product problems
- Temperature Problem
- Temperature Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT THE "DEVICE BURNED A HOLE ON THE SIDE OF THE UNIT." FURTHER INFORMATION HAS BEEN REQUESTED.
Additional Manufacturer Narrative
ONE INTELECT MOBILE 2-CHANNEL STIM INTERNATIONAL STANDARD UNIT WAS RETURNED FOR EVALUATION. THE POWER SUPPLY UNIT (PSU) WAS NOTED TO HAVE BEEN HELD BY ONE SCREW INSTEAD OF TWO AS NORMAL. THIS IS INDICATIVE OF INSUFFICIENT ELECTRICAL INSTALLATION BY THE END USER SITE. THE PSU WAS SHIFTED ON ONE SIDE. THE BURN STARTED BY THE 230 VOLT INPUT. AN INTERNAL METAL STRUCTURAL COMPONENT WAS FOUND TO HAVE RUSTED. THERE IS WHITE RESIDUE IN CONJUNCTION WITH THE RUST, WHICH INDICATES WATER INGRESS HAD OCCURRED. IT IS MOST LIKELY THAT WATER ENTERED THE UNIT, CAUSING A SHORT-CIRCUIT.