MEDLINE
Received Mar 4, 2026 · Event occurred Feb 4, 2026
Report 1417592-2026-00183 · MDR key 24513524
Device
Generic name
Adult Resus Bag,tube Res,mano,peep,filt
Manufacturer
Medline Industries, LpCatalog number
CPRM4426FPWM
Lot number
582867
Product problems
- Gas/Air Leak
Patient
Not reported
- Cardiac Arrest
- Hypoventilation
- Hypoxia
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE CUSTOMER CONTACT ON (B)(6) 2026, RESUSCITATION BAG WAS BEING USED DURING A RESUSCITATION ON A PATIENT BROUGHT INTO THE ER. IT WAS REPORTED "BAG LEAKING AIR/ OXYGEN AREA POPPING OFF THE BACK CAUSING LACK OF OXYGEN DURING RESUSCITATION". ONCE THE ISSUE OCCURRED, THE THERAPIST WAS SWITCHING OUT THE BAG, BUT A CODE BLUE WAS CALLED. PATIENT EXPIRED AND CAUSE OF DEATH WAS REPORTED AS "CARDIAC ARREST. " PER THE FACILITY, IT IS "UNKNOWN" IF THE PRODUCT CAUSED OR CONTRIBUTED TO THE DEATH. INFORMATION RECEIVED TO-DATE HAS BEEN EVALUATED. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO DEATH, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.
Description of Event or Problem
ACCORDING TO THE CUSTOMER CONTACT ON (B)(6) 2026, RESUSCITATION BAG WAS BEING USED DURING A RESUSCITATION ON A PATIENT BROUGHT INTO THE ER. IT WAS REPORTED "BAG LEAKING AIR/ OXYGEN AREA POPPING OFF THE BACK CAUSING LACK OF OXYGEN DURING RESUSCITATION." PATIENT EXPIRED AND CAUSE OF DEATH WAS REPORTED AS "CARDIAC ARREST."