PROVITA

Description of Event or Problem

THIS IS A SURGICAL LAMP FOR USE IN MRI ENVIRONMENTS UP TO 3 TESLA. IT IS BATTERY OPERATED, EMPLOYING A LITHIUM ION RECHARGEABLE BATTERY. THE UNIT IS UL LISTED. WE HAVE BECOME AWARE OF A BATTERY FAILURE, DEVICE NAME: SERIES 1 MOBILE LED UL/MRI-LAMP WITH BATTERY. SYMPTOM: BATTERY OVERHEATED WHILE BEING CHARGED. THE OVERHEATING DAMAGED THE BATTERY HOUSING CAUSING CHARRING AND EMITTING SMOKE. ACCORDING TO THE USER FACILITY REPORTING THE INCIDENT, TWO PERSONS SUFFERED SMOKE INHALATION. SINCE TWO WERE AFFECTED THERE ARE TWO MDR REPORTS. THIS IS REPORT NUMBER 2 OF 2. BOTH PERSONS RETURNED TO WORK WITHOUT RECEIVING SERIOUS OR PERMANENT INJURY. NO PATIENTS WERE INVOLVED. WE HAVE BEEN UNABLE TO OBTAIN FULL DETAILS OF THE EVENT BECAUSE OF LACK OF DETAILED RESPONSES FROM THE USER FACILITY.

Additional Manufacturer Narrative

ADDED RELATED REPORT NUMBER AND MADE FDA REQUESTED CORRECTIONS.