FDA Adverse Event Malfunction Summary report: N

NIOBE MNS PHILIPS

MDR report key: 10517824 · Received September 10, 2020

Report

Report Number
3003084417-2020-00324
Event Type
Malfunction
Date Received
September 10, 2020
Date of Event
August 12, 2020
Report Date
September 10, 2020
Manufacturer
STEREOTAXIS
Product Code
NDQ
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
PA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

ON (B)(6) 2020, WHILE DOING A MANUAL PROCEDURE, THE ODYSSEY WOULD NOT BOOT PAST THE LOADING SCREEN. THE LOCAL CLINICAL SPECIALIST REPLACED THE NIOBE ROUTER WITH AN OFF THE SHELF NETWORK SWITCH. IT WAS NOTED BY THE CLINICAL SPECIALIST THAT IT WAS EXTREMELY HOT IN THE CONTROL ROOM. MAINTENANCE TURNED ON THE AIR CONDITIONER AND COOL AIR WAS BLOWING INTO THE ROOM. THE NEXT MORNING ((B)(6) 2020) LAB PERSONNEL TURNED ON THE NIOBE SYSTEM, AND WITHIN A FEW MINUTES, A HAZE AND ELECTRICAL BURN SMELL WAS NOTED. LAB PERSONNEL WENT INTO THE CONTROL ROOM, AND THE NIOBE CABINET WAS GLOWING. THEY DEPLOYED A FIRE EXTINGUISHER. MAINTENANCE WAS CALLED, OPENED THE CABINET ,AND NOTED THAT THERE WAS A FIRE ON THE MCC COMPUTER. THE FIRE WAS EXTINGUISHED. IT WAS NOTED THAT THE AIR CONDITIONER WAS NOT OPERATING AT THIS TIME. WITHIN THE HOUR, A SERVICE TECHNICIAN FROM STEREOTAXIS ENTERED THE CONTROL ROOM. THE TEMPERATURE WAS RECORDED AT 120 F. IT WAS LEARNED THAT EARLIER THAT WEEK, THERE WAS A STORM THAT KNOCKED POWER TO THE NIOBE LAB, AND THAT A VEHICLE HAD RUN INTO A POWER POLE NEAR THE HOSPITAL. THE NIOBE LAB AND THE AIR CONDITIONER ARE ON SEPARATE POWER SUPPLIES, AND THE AIR CONDITIONER REMAINED ON EMERGENCY POWER DURING THIS EVENT. THE HOSPITAL IS RETURNING ALL OF THE DAMAGED COMPONENTS FOR INSPECTION. THERE WAS NO PATIENT IN THE ROOM, AND THERE WAS NO INJURY TO PATIENT OR STAFF. THE DAMAGED UNIT WAS RECEIVED TO STEREOTAXIS AND THE INITIAL REVIEW DETERMINED THAT THE FIRE STARTED AT THE CDROM DRIVE CONNECTION. THE UNIT WAS SHIPPED TO THE PC MANUFACTURER FOR AN EXPEDITED INVESTIGATION. A REPORT FROM DEDICATED COMPUTING, WHO MANUFACTURES THE COMPUTERS, DETERMINED THAT THE ROOT CAUSE OF THE FIRE WAS DUE TO A DEFECTIVE MOLEX TO SATA ADAPTER CABLE USED TO POWER THE SYSTEM'S OPTICAL DRIVE. CABLES DISPLAY SIGNIFICANT THERMAL DAMAGE TO THE SATA END OF THE CABLE NEAREST THE DRIVE AND ALIGNED WITH THE 12V/GND CONNECTION (SATA POWER PINS 13-15 AND 10-12 RESPECTIVELY). THIS DAMAGE IS CONSISTENT WITH A SUSTAINED ELECTRICAL ARC BETWEEN THE 12V AND GND CONDUCTORS. IN ORDER FOR THIS SUSTAINED ARC TO OCCUR, ARC CURRENT MUST HAVE BEEN LESS THAN THE OVERCURRENT THRESHOLD OF THE SYSTEMS POWER SUPPLY. IN CONCLUSION, IT APPEARS THAT A PART FAILURE IN THE COMPUTER LED TO THE FIRE, AND A CONTRIBUTING FACTOR MAY HAVE BEEN THE EXTREME TEMPERATURE IN THE CONTROL ROOM WHEN THE SYSTEM WAS STARTED UP. THERE WAS NO INJURY TO EITHER PATIENTS OR STAFF, HOWEVER, IF THIS TYPE OF EVENT WERE TO OCCUR AGAIN, IT COULD LEAD TO PATIENT OR STAFF INJURY. BASED ON THIS INFORMATION, IT IS RECOMMENDED THAT THIS EVENT BE REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
983693 NIOBE MNS PHILIPS NIOBE ES NDQ STEREOTAXIS ES PHILIPS

Patients

Seq Age Sex Outcome Treatment
1