Description of Event or Problem · 1
FACILITY NOTIFIED (B)(4) WHEN THE SWITCH ON THE SIDE TOWER WAS TURNED ON IT MADE A CRACKLING SOUND AND SEEMED TO SPARK. CART WAS TURNED OFF AND UNPLUGGED TWICE BEFORE ATTEMPTING TO TURN ON THE SAME THING HAPPENED TWO MORE TIMES. DOCTOR THEN PUSHED EACH CORDS ENDS AND JOSTLED THEM AROUND. THIS TIME WHEN SWITCH TURNED ON THE EQUIPMENT ON THE CART STARTED UP. NO INJURIES TO A PATIENT OR STAFF MEMBER WAS REPORTED. DEVICE IN QUESTION IS "DROP SHIPPED", MEANING IT IS DELIVERED FROM THE MANUFACTURER TO THE CUSTOMER WITHOUT STOPPING AT THE IMPORTER FACILITY (B)(4) FOR ANY TESTING, INSPECTION OR RE-LABELING. AN INVESTIGATION WILL NOT BE PERFORMED BY (B)(4) AS DEVICE IN QUESTIONED IS MANUFACTURED BY OMNI CORPORATION. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SUBMITTED TO FACILITY, NO RESPONSE AS OF 08/10/2015. (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFORMATION, WE WILL PROVIDE MANUFACTURER WITH FOLLOW-UP INFORMATION. AN INVESTIGATION WILL NOT BE PERFORMED BY (B)(4) AS DEVICE IN QUESTIONED IS MANUFACTURED BY OMNI CORPORATION. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SUBMITTED TO FACILITY, NO RESPONSE AS OF 08/10/2015. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SUBMITTED TO FACILITY, NO RESPONSE AS OF 08/10/2015. (B)(4) CONSIDERS THIS MATTER CLOSED. HOWEVER, IN THE EVENT WE RECEIVE ADDITIONAL INFORMATION, WE WILL PROVIDE MANUFACTURER WITH FOLLOW-UP INFORMATION.