AQUATHERM III HEATER,ADJUST,LVN
Received May 23, 2026 · Event occurred Apr 23, 2026
Report 1417592-2026-01728 · MDR key 25266383
Device
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
CUSTOMER REPORTED DAMAGE, A GASKET ON THE RESERVOIR SIDE IS CRACKED AND BROKEN.
Additional Manufacturer Narrative
CUSTOMER REPORTED DAMAGE, A GASKET ON THE RESERVOIR SIDE IS CRACKED AND BROKEN. DUE DILIGENCE HAS BEEN COMPLETED. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE CUSTOMER CONTACT WAS UNABLE OR UNWILLING TO PROVIDE FURTHER INCIDENT DETAILS TO THE MANUFACTURER. THERE WERE NO REPORTS OF DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, OR FOLLOW UP CARE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR AGAIN. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.