inforMED
InjuryBTM

MEDLINE

Received Mar 4, 2026 · Event occurred Feb 4, 2026

Report 1417592-2026-00179 · MDR key 24513317

Device

Generic name

Resus,man,adlt,bag Res,peep,mano,filt

Model number

CPRM4416FPM

Lot number

555593

Product problems

  • Leak/Splash

Patient

NA · Unknown

  • Respiratory Insufficiency

Narrative

Additional Manufacturer Narrative

UPDATE TO H6: TYPE OF INVESTIGATION (B). UPDATE TO H6: INVESTIGATION FINDINGS (C). UPDATE TO H6: INVESTIGATION CONCLUSIONS (D).

Description of Event or Problem

ACCORDING TO THE FACILITY, "CODE BLUE ED THERAPIST WAS BAGGING PATIENT HEARD A LOUD SWISHING NOISE PATIENT O2 SAT STARTED DROPPING. SWITCHED OUT BAG AND O2 SAT STARTING RISING"

Additional Manufacturer Narrative

ACCORDING TO THE FACILITY, "CODE BLUE ED THERAPIST WAS BAGGING PATIENT HEARD A LOUD SWISHING NOISE PATIENT O2 SAT STARTED DROPPING. SWITCHED OUT BAG AND O2 SAT STARTING RISING". THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE HOSPITAL. THE FACILITY STATED, "WHEN THE PATIENT LEFT THE FACILITY TO BE TRANSFERRED THE PATIENT WAS VENTILATED". NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE. THE SAMPLE WAS REQUESTED FOR EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO (DEATH/SERIOUS INJURY), THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.