OR1 FLEXRACK, PS16B, NEO IP

Additional Manufacturer Narrative

DEVICE EVALUATION: POSSIBLE CAUSES: THERMAL OR ELECTRICAL STRESS WITHIN THE UPS BATTERY DURING/AFTER THE HOSPITAL'S MONTHLY GENERATOR TEST, LEADING TO INTERNAL BATTERY FAILURE AND EXPANSION. UPS FAILURE CAUSED BY BATTERY SWELLING/BLOATING, WHICH IS CONSISTENT WITH OVERCURRENT, OVER-TEMPERATURE, OR END-OF-LIFE CHEMICAL INSTABILITY IN SEALED BATTERIES. CONTRIBUTING FACTORS: UPS WAS RACK-MOUNTED IN AN ENCLOSED SPACE, WHICH MAY INCREASE HEAT EXPOSURE. BATTERY LIKELY CROSSING THE END OF SERVICE LIFE SINCE THE UNIT IS MORE THAN 2 YEARS OLD. LACK OF PLANNING OR PREVENTIVE MAINTENANCE SCHEDULE OR END-OF-LIFE TRACKING FOR UPS BATTERIES FROM CUSTOMER END. THE ISSUE WAS RESOLVED BY REPLACING DEFECTIVE RACK MOUNT UPS WITH A BRAND NEW POWERVAR UPS UNIT (WUIS3519) AND BY VERIFYING FULL FUNCTIONALITY. NO FURTHER ISSUES NOTED. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. RATHER, THEY WILL SEND A SERVICE TECH TO EVALUATE THE DEVICE IN THE FIELD. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS PRODUCT IS MANUFACTURED AT KARL STORZ ENDOSCOPY AMERICA, 13803 N PROMENADE BLVD, STAFFORD, TX 77477; HOWEVER, IT IS DESIGNED IN GERMANY. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Description of Event or Problem

ACCORDING TO THE EVENT DESCRIPTION "L2 KFKOR002 - L2 DUE TO BURNING SMELL IN THE ROOM. KFK ROOM 2 - CUSTOMER SMELLED A BURNING SMELL IN THE ROOM AND SAYS IT'S COMING FROM THE AMX CONTROLLER." THERE IS NO INFORMATION THAT THE EVENT CAUSED A HARM OR SERIOUS INJURY TO PATIENT, USER OR THIRD PARTY.