inforMED
InjuryBTM

SUNMED

Received Feb 21, 2022 · Event occurred Dec 15, 2021

Report 1314417-2022-00007 · MDR key 13573204

Device

Generic name

Small Adult Airflow W/manometer

Model number

AF5140MB

Lot number

312679

Product problems

  • Difficult to Open or Close

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Additional Manufacturer Narrative

THE PATIENT COULD NOT RECEIVE PROPER RESPIRATORY SUPPORT AND WAS REPORTED TO BE UNRESPONSIVE. SUMMARY: THE CUTTING PROCESS USED FOR THE PATIENT VALVE DUCKBILL IS THE LIKELY ROOT CAUSE FOR THE DUCKBILL BEING SEALED. ON 5/10/2019, THE DRAWING FOR THE DUCKBILL WAS UPDATED TO ADD A BLADE SPECIFICATION TO REDUCE THE MATERIAL'S ABILITY TO RE-ADHERE AFTER CUTTING. RA: SEALED DUCKBILL HAS WORST-POTENTIAL SEVERITY OF 9 - HAZARDOUS. THIS COMPLAINT WILL BE BROUGHT TO CARB FOR REVIEW. HOWEVER, RISK IS ALREADY MITIGATED SIGNIFICANTLY WITH IN-PROCESS INSPECTION REQUIREMENTS, BLADE SPECIFICATION ADDED 5/10/2019, AND IFU REQUIREMENTS TO TEST THE RESUSCITATION BAG PRIOR TO USE.

Description of Event or Problem

DUCK BILL SEALED SHUT. CUSTOMER WAS UNRESPONSIVE, USED THE AF5140MB THE DUCK BILL VALVE WOULD NOT ALLOW THE AIR TO BE SQUEEZED OUT OF IT. PATIENT WOKE UP AFTERWARDS. THEY TRIED AGAIN AND WITH A LOT OF PRESSURE IT WORKED.

Additional Manufacturer Narrative

THE PATIENT COULD NOT RECEIVE PROPER RESPIRATORY SUPPORT AND WAS REPORTED TO BE UNRESPONSIVE. SUMMARY: THE CUTTING PROCESS USED FOR THE PATIENT VALVE DUCKBILL IS THE LIKELY ROOT CAUSE FOR THE DUCKBILL BEING SEALED. ON (B)(6) 2019, THE DRAWING FOR THE DUCKBILL WAS UPDATED TO ADD A BLADE SPECIFICATION TO REDUCE THE MATERIAL'S ABILITY TO RE-ADHERE AFTER CUTTING. RA: SEALED DUCKBILL HAS WORST-POTENTIAL SEVERITY OF 9 - HAZARDOUS. THIS COMPLAINT WILL BE BROUGHT TO CARB FOR REVIEW. HOWEVER, RISK IS ALREADY MITIGATED SIGNIFICANTLY WITH IN-PROCESS INSPECTION REQUIREMENTS, BLADE SPECIFICATION ADDED (B)(6) 2019, AND IFU REQUIREMENTS TO TEST THE RESUSCITATION BAG PRIOR TO USE.

Description of Event or Problem

DUCK BILL SEALED SHUT. CUSTOMER WAS UNRESPONSIVE, USED THE AF5140MB THE DUCK BILL VALVE WOULD NOT ALLOW THE AIR TO BE SQUEEZED OUT OF IT. PATIENT WOKE UP AFTERWARDS. THEY TRIED AGAIN AND WITH A LOT OF PRESSURE IT WORKED.