OHIO MEDICAL

Additional Manufacturer Narrative

ORIGINAL EVENT (AS REPORTED ON (B)(4)) DESCRIPTION: "RESPIRATORY ARREST WITH PATIENT HAVING POOLING OF FECULENT VOMIT IN OROPHARYNX. CODE TEAM UNABLE TO EMERGENTLY INTUBATE DUE TO NO FUNCTIONING WALL-SUCTION IN THE ROOM. PER RT (RESPIRATORY THERAPIST) AND NURSING STAFF, SUCTION WAS NOT FUNCTIONING. PORTABLE SUCTION WAS OBTAINED BY RT TEAM, AND PATIENT WAS EVENTUALLY INTUBATED HOWEVER NOT HAVING SUCTION AVAILABLE DURING RESPIRATORY ARREST EVEN DURING EMERGENT INTUBATION WAS A DELAY. DART (DISTRESS ACTIVATION RESPONSE TEAM) WAS CALLED BUT PRIOR TO THEIR ARRIVAL ETT (ENDOTRACHEAL TUBE) WAS PLACED USING PORTABLE SUCTION OBTAINED BY RT. PATIENT ULTIMATELY DIED DESPITE CPR AND RESUSCITATIVE EFFORTS. WALL SUCTION REGULATOR MALFUNCTIONED. WALL SUCTION FUNCTIONING PROPERLY. ENGINEERING REPORTED TO ROOM AND CHECKED THE REPORT OF NO SUCTION. TECH FOUND A BAD SUCTION REGULATOR ON THE WALL TECH, REMOVED THE REGULATOR AND INSTALLED TEST OUR TEST UNIT AND FOUND WALL OUTLET TO BE WORKING CORRECTLY. TECH INFORMED NURSING THEY NEEDED TO CONTACT RESPIRATORY THERAPY FOR A REPLACEMENT UNIT. DEVICE FAILED." COMPLAINT DATA/ TRENDS WERE ANALYZED AND IT WAS DETERMINED THAT FREQUENCY OF WHAT WOULD BE REPORTED AS "LOW OR NO VACUUM" ALIGNS WITH FREQUENCY RATE AS DOCUMENTED IN DEVICE FAILURE MODES AND EFFECTS ANALYSIS. DEVICE INSTRUCTIONS FOR USE WAS REVIEWED AND THE FOLLOWING IS STATED "WARNING: THE PRE-USE CHECKOUT PROCEDURE MUST BE PERFORMED BEFORE USING THE EQUIPMENT ON EACH PATIENT. IF THE REGULATOR FAILS ANY PART OF THE PRE-USE CHECKOUT PROCEDURE, IT MUST BE REMOVED FROM SERVICE AND REPAIRED BY QUALIFIED SERVICE PERSONNEL." THE ALLEGED FAILURE (OHIO MEDICAL WAS UNABLE TO REPLICATE THE FAILURE IN OUR TESTING OF THIS DEVICE) DESCRIBED SHOULD HAVE BEEN IDENTIFIED DURING THE PRE-USE CHECKOUT PROCEDURE. IT IS THEORIZED BASED ON RESULTS OF DEVICE EVALUATION THAT THIS EVENT OCCURRED DUE TO USER ERROR. IT SHOULD BE NOTED THAT WHILE SET TO "INTERMITTENT" THE DEVICE CYCLE BEGINS IN THE "OFF" MODE AS SPECIFIED IN INSTRUCTIONS FOR USE. OTHER FACTORS THAT WOULD INFLUENCE VACUUM LEVEL WOULD BE IMPROPER CONNECTIONS BETWEEN TUBING, FILTER, VACUUM REGULATOR, COLLECTION BOTTLE AND TRAP JAR OR A FULL TRAP JAR, WHICH IS INTENDED TO STOP FLOW OF VACUUM IN ORDER TO PROTECT SOURCE PRESSURE. HEALTH AND HAZARDS EVALUATION WAS PERFORMED, WITH INPUT PROVIDED FROM CLINICAL REPRESENTATIVE. IT WAS DETERMINED, BASED ON RESULT OF DEVICE EVALUATION AND REVIEW OF FAILURE OCCURENCE THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.

Description of Event or Problem

ON MAY 9, 2022 - A REQUEST WAS RECEIVED FROM (B)(4) OF THE US FDA REQUESTING ADDITIONAL INFORMATION REGARDING USER FACILITY REPORT (B)(4). UPON RECEIPT OF THIS REQUEST OHIO MEDICAL COMPLAINT AND ADVERSE EVENT DATA WAS REVIEWED AND IT WAS DETERMINED THAT OHIO MEDICAL HAD NOT YET BECOME AWARE OF THE EVENT DESCRIBED. USER FACILITY INITIAL REPORTER (B)(6) WAS IMMEDIATELY CONTACTED BY TELEPHONE TO REQUEST RETURN OF THE SUSPECT DEVICE AS WELL AS ANY ADDITIONAL INFORMATION THAT COULD BE PROVIDED .