BAGEASY

Description of Event or Problem

THE REPORTED ISSUE: "WHEN MY STAFF WENT TO USE THE AMBU BAG, THEY WERE UNABLE TO SQUEEZE IT. IT WAS LIKE THERE WAS AN OBSTRUCTION NOT ALLOWING THE BAG TO BE SQUEEZED. LATER STAFF SQUEEZED IT AS HARD AS THEY COULD AND HEARD A "POP." THEN THEY WERE ABLE TO SQUEEZE THE BAG NORMALLY. WHEN KRISTIE AND I TOOK THE BAG APART TO INSPECT IT WE FOUND A PLASTIC VALVE RIGHT WHERE THE DEVICE CONNECTS TO THE AIRWAY. YOU COULD TELL THE PLASTIC WAS RIPPED FROM WHERE IT POPPED WHEN THE STAFF SQUEEZED THE BAG REALLY HARD. IT APPEARS THE VALVE WAS SEALED SHUT INSTEAD OF OPENING LIKE IT SHOULD HAVE." THIS HAS BEEN DOCUMENTED AS SINGLE EVENT FOR THE DEVICE, THEREFORE ONLY ONE MDR WILL BE SUBMITTED.

Additional Manufacturer Narrative

H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): MANUAL RESUSCITATION BAG. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 23 JAN 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE COMPLAINT OF "IT WAS LIKE THERE WAS AN OBSTRUCTION NOT ALLOWING THE BAG TO BE SQUEEZED" REGARDING PART 562048 WAS NOT CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED BUT COULD POSSIBLY BE A RESULT OF MFG ERROR - PATIENT VALVE (DUCKBILL) DOES NOT OPEN. A RISK ASSESSMENT WAS PERFORMED AND THE ULTIMATE RISK WAS DETERMINED TO BE MEDIUM WHICH DOES REQUIRE ESCALATION TO THE CAPA REVIEW BOARD. THERE HAS BEEN 1 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THIS REPORTED EVENT. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

Additional Manufacturer Narrative

H6: 4756 (APPROPRIATE IMPACT TERM/CODE NOT AVAILABLE): MANUAL RESUSCITATION BAG. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 23 JAN 2025 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IS IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

Description of Event or Problem

THE REPORTED ISSUE: "WHEN MY STAFF WENT TO USE THE AMBU BAG, THEY WERE UNABLE TO SQUEEZE IT. IT WAS LIKE THERE WAS AN OBSTRUCTION NOT ALLOWING THE BAG TO BE SQUEEZED. LATER STAFF SQUEEZED IT AS HARD AS THEY COULD AND HEARD A "POP." THEN THEY WERE ABLE TO SQUEEZE THE BAG NORMALLY. WHEN KRISTIE AND I TOOK THE BAG APART TO INSPECT IT WE FOUND A PLASTIC VALVE RIGHT WHERE THE DEVICE CONNECTS TO THE AIRWAY. YOU COULD TELL THE PLASTIC WAS RIPPED FROM WHERE IT POPPED WHEN THE STAFF SQUEEZED THE BAG REALLY HARD. IT APPEARS THE VALVE WAS SEALED SHUT INSTEAD OF OPENING LIKE IT SHOULD HAVE." THIS HAS BEEN DOCUMENTED AS SINGLE EVENT FOR THE DEVICE, THEREFORE ONLY ONE MDR WILL BE SUBMITTED.