Additional Manufacturer Narrative · 1
SMITHS MEDICAL PM, INC. IMPORTS THE PNEUPAC TRANSPORT VENTILATOR FROM SMITHS MEDICAL INTERNATIONAL, LTD. SMITHS MEDICAL PM, INC. KITS THE DISPOSABLE PT CIRCUIT (CAT. NO. 122002) AND PACKAGES THE DISPOSABLE PT CIRCUIT ALONG WITH THE VENTILATOR. THE INFO THAT HAS BEEN PROVIDED TO USE FROM THE USER FACILITY CLEARLY STATES THAT THE USER INCORRECTLY CONFIGURED THE PT CIRCUIT WHEN HOOKING UP THE PT TO THE VENTILATOR RESULTING IN FAILURE TO VENTILATE THE PT. THE USER ATTACHED THE PT HOSE TO THE PORT ON THE PT VALVE THAT IS SUPPOSED TO BE ATTACHED TO THE PT'S MASK OR ENDOTRACH TUBE INSTEAD OF THE FIXED SIDE LIMB WHERE IT IS SUPPOSED TO BE ATTACHED. (SEE PHOTO #1-PICTURE PROVIDED TO US FROM THE USER FACILITY; PHOTO #1A-RE-CREATION OF HOW THE INCORRECTLY CONFIGURED THE PT CIRCUIT DONE BY SMITHS MEDICAL PM, INC.) FOR PROPER CONFIGURATION, SEE PHOTO # 2. ALL LABELING AND INSTRUCTIONS FOR USE INCLUDED WITH BOTH THE PT CIRCUIT AND THE VENTILATOR WERE REVIEWED. THE PT VALVE DOES HAVE AN ARROW WITH "PATIENT" UNDER IT INDICATING THE DIRECTION OF FLOW TO THE PT CONNECTION. THE PT CIRCUIT CONFIGURATION IS SHOWN ON THE INSERT THAT IS INCLUDED WITH EACH PT CIRCUIT, P/N, AND IN THE OPERATIONS MANUAL PGS 19 & 20. A WARNING IS INCLUDED IN THE MANUAL AS FOLLOWS: "TO AVOID HARM TO THE PT, PRE-USE CHECKS MUST BE PERFORMED (SEE SECTION 3 (A) AND 3 (B) POINTS #1 TO #8 INCLUSIVE) BEFORE EACH USE." IF THE USER PERFORMED THE PRE-USE CHECKS, WHEN CHECKING FOR FLOW FROM THE PORT THEY USED TO ATTACH TO THE ET TUBE BY PLACING THE PORT CLOSE TO THE BACK OF THEIR HAND OR FACE (STEP 5-PRE-USE CHECKS), THEY SHOULD HAVE NOTICED NO FLOW COMING FROM THE PORT. THE VENTILATOR USED AT THE TIME OF THE INCIDENT, DID ALARM. THERE WAS NO INDICATION FROM THE USER FACILITY THAT THE VENTILATOR MALFUNCTIONED IN ANY WAY. THE VENTILATOR WAS RETURNED TO SMITHS MEDICAL PM, INC. AND FORWARDED ON TO SMITHS MEDICAL INTERNATIONAL TO BE EVALUATED. THE PT CIRCUIT WAS DISCARDED AT THE TIME OF THE INCIDENT, SO IT IS NOT AVAILABLE.