inforMED
MalfunctionBYX

O2 / AIR HOSES

Received Jun 30, 2020 · Event occurred Jun 1, 2020

Report 2523148-2020-00002 · MDR key 10213422

Device

Generic name

O2 / Air Hoses

Model number

519012 / 519174

Catalog number

519012 / 519174

Lot number

0212180001 / 0212180002

Product problems

  • Device Misassembled During Manufacturing /Shipping
  • Device Misassembled During Manufacturing /Shipping

Patient

Not reported

  • No Consequences Or Impact To Patient
  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

(2EA - 519012 (HOSE ASSY, AIR,DISS FHT, DISS FHX, 4') & (2EA - HOSE ASSY, O2, DISS FHT, DISS M, 4') RETURNED FOR INVESTIGATION. (2) HOSE ASSEMBLIES (519012) RETURNED TESTED - NO PROBLEM FOUND - FERRULES PROPERLY CRIMPED. (2) HOSE ASSEMBLIES (519174) RETURNED: (1) - FERRULE NOT CRIMPED PROPERLY (1) - FERRULE WAS MISSING WHICH WAS THE INCIDENT DEFINED IN THE DETAILS OF THE INCIDENT. HOSE ASSEMBLIES ARE FROM FEB 2018 IN EXCESS OF 2 YEARS OLD. IT IS UNKNOWN THE USE OF THE HOSE ASSEMBLY SINCE PURCHASED. REVIEW OF WORK INSTRUCTION DEFINES THE CRIMPING PROCESS AND TESTING PROCESS REVIEWED REPAIRS AND COMPLAINTS - NO OTHER COMPLAINTS OF THIS NATURE NOTE: ONLY ONE SHIPMENT OF 3EA (519174) HOSE ASSEMBLY WAS MADE IN FEB 2018. NO OTHER SHIPMENTS OF THIS ASSEMBLY RE-TRAIN ASSEMBLERS ON WORK INSTRUCTION MDFT120 "MEDICAL HOSE ASSEMBLY & TEST" AND MONITOR FOR ANY TRENDING

Description of Event or Problem

AN AHS STAFF MEMBER REPORTED A NEAR MISS WHERE THEY WERE ALMOST INJURED DUE TO THE OXYGEN BLENDER HOSE DETACHING FROM THE WALL AND THE METAL COUPLING AT THE END SHOOTING OUT. THE STAFF MEMBER INVESTIGATED THAT BLENDER HOSE AS IT WAS MAKING A "HISSING" SOUND. WHEN THE STAFF TOUCHED IT, IT CAME APART AND CAME SHOOTING OUT OF THE WALL UNDER GREAT PRESSURE AND THE METAL COUPLING DEVICE FLEW TOWARDS THEM. FORTUNATELY, THE STAFF MEMBER WAS NOT INJURED AS THEY WERE WAS STANDING TO THE "SIDE" OF THIS DEVICE. HAD THEY BEEN IN FRONT OF IT, THEY COULD HAVE BEEN INJURED AS THE METAL PIECE FLEW WITH GREAT SPEED DUE TO THE PSI OF THE GAS FLOWING OUT. STAFF NOTICED ANOTHER OXYGEN BLENDER HOSE HISSING IN DIFFERENT LOCATION. STAFF WAS APPREHENSIVE TO MOVE THE HOSE DUE TO WHAT OCCURRED PREVIOUSLY. BIOMED CAME UP SHORTLY AFTER AND REPORTED THAT THE WRONG TYPE OF END WAS ON THE OXYGEN BLENDER HOSE. BIOMED SAID THIS TYPE OF END WAS NOT CSA APPROVED. THIS WAS THE SAME END THAT WAS ON THE ORIGINAL BLENDER MAY.

Remedial action

  • Notification
  • Inspection