AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL

Additional Manufacturer Narrative

EXEMPTION NUMBER: E2014018. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL "DURING A CERVICAL SURGICAL PROCEDURE THERE WAS A LOUD EXPLOSION SOUND AND THE PRESSURE FROM THE BROKEN PIECE OF THE AIR HOSE HIT THE NURSE AND CAUSE THE NURSE TO HAVE CHEST PAINS AND DIFFICULTY BREATHING. IMMEDIATELY FOLLOW THE INCIDENT THE NURSE WAS EXAMINED AND HAD AN X-RAY SHOWING NO FRACTURE TO THE CHEST. ON (B)(6) 2018 STILL FEELING TIGHTNESS OF THE CHEST AND NOT BREATHING SMOOTHLY THE NURSE WAS SEEN BY A DOCTOR IN THE DEPARTMENT OF THORACIC MEDICINE AND RELEASED TO GO BACK TO WORK. BEFORE THE EXPLOSION, THE HOSE WAS COMPLETE WITHOUT ANY MISSING PARTS. THE BROKEN PIECE WAS FOUND IN FRONT OF THE NURSE.

Additional Manufacturer Narrative

WE DID RECEIVE THE PRODUCT IN A DECONTAMINATED CONDITION FOR INVESTIGATION. THE OUTER AIR HOSE BUSTED AT THE HAND PIECE-SIDE. THE AIR HOSE WAS DISTRIBUTED AT THE 08 JULY 2015. THE MAINTENANCE INTERVAL HAS EXCEEDED. A MAINTENANCE WOULD HAVE BEEN NECESSARY IN 2016-08. THE OUTER AIR HOSE BUSTED AT THE HAND PIECE CONNECTION SIDE. NO FURTHER DAMAGES COULD BE FOUND AT THE HOSE. THE INTERIOR IS SLIGHTLY STAINED. THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION FOR A MANUFACTURING FAILURE. NO FURTHER COMPLAINT REGISTERED AGAINST THE SAME LOT NUMBER. THE FAILURE IS MOST PROBABLY USAGE/MAINTENANCE RELATED. BASED ON THE INFORMATION PROVIDED AS WELL AS AFTER THE INVESTIGATION, WE ASSUME THAT A USAGE RELATED FAILURE (E.G. A KINKING) IN A COMBINATION WITH WEAR AND TEAR LED TO THE DESCRIBED FAILURE PATTERN. A MAINTENANCE DID NOT TAKE PLACE SINCE THE AIR HOSE WAS DISTRIBUTED. ACCORDING TO OUR IFU, A MAINTENANCE MUST BE EXECUTED AT LEAST ONCE A YEAR. EXCERPT FROM IFU: TO ENSURE RELIABLE OPERATION, THE PRODUCT MUST BE MAINTAINED AT LEAST ONCE A YEAR IN ACCORDANCE WITH THE MAINTENANCE LABELING; SEE MAINTENANCE LABEL. NO CAPA IS NECESSARY.