PIEZOWAVE2

Description of Event or Problem

ACCORDING TO THE INFORMATION RECEIVED, A FAULT MESSAGE AND SUBSEQUENT SMOKE DEVELOPMENT OCCURRED DURING AN APPLICATION OF THE PIEZOWAVE 2. THE PIEZOWAVE WAS DISCONNECTED FROM THE POWER SUPPLY. THE USER REPORTS THAT THERE WAS NO DANGER TO THE PATIENT.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE NEW INFORMATION: B4, D8, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS), H7, H8, AND H11. THE INVESTIGATIONS REVEALED THAT A HIGH-VOLTAGE CAPACITOR HAD A MANUFACTURING DEFECT. THE COATED BASE MATERIAL (FILM) HAD A DEFECTIVE COATING ON A ROLL OF FILM. THE CAPACITORS MANUFACTURED FROM THIS MATERIAL CAN EXHIBIT A SIMILAR DEFECT. DEPENDING ON THE VOLTAGE AND CURRENT LOAD, ELECTRICAL BREAKDOWNS OCCUR IN THE CAPACITOR, WHICH CAN LEAD TO SMOKE DEVELOPMENT, WHICH IS CONVEYED TO THE OUTSIDE BY THE VENTILATION FAN. THE MATERIALS USED ARE SELF-EXTINGUISHING. WE THEREFORE ASSUME THAT THE USER SUSPECTED A FIRE DUE TO THE SMOKE. DUE TO THE MANUFACTURING DEFECT AT THE MANUFACTURER CAPACITOR AND THIS INCIDENT, RICHARD WOLF HAS DECIDED TO INSPECT ALL DEVICES ON THE MARKET THAT CONTAIN CAPACITORS FROM THE AFFECTED FILM ROLL. THE MEASURE WAS REPORTED TO THE FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES (BUNDESINSTITUT FÜR ARZNEIMITTEL UND MEDIZINPRODUKTE, BFARM ) AND IS LISTED UNDER THE BFARM CASE NUMBER: (B)(4). ADDITIONALLY, THERE ARE NO DEVICES IN US THAT WAS AFFECTED BY THE RECALL ACTION.