AIRCAST
Received Apr 1, 2025 · Event occurred Mar 5, 2025
Report 9616086-2025-00035 · MDR key 21748994
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
- Adverse Event Without Identified Device or Use Problem
- Patient Device Interaction Problem
Patient
NA · Female
- Pain
- Electric Shock
- Pain
- Electric Shock
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE PATIENT THAT THE UNIT IS GIVING ELECTRIC SHOCKS AND PAIN THAT LASTED UP TO TWO WEEKS.
Additional Manufacturer Narrative
IT WAS REPORTED BY THE PATIENT THAT THE UNIT IS GIVING ELECTRIC SHOCKS AND PAIN THAT LASTED UP TO TWO WEEKS. THE PATIENT TRIED UNPLUGGING THE UNIT AND PLUGGING IT BACK IN, THE DEVICE WAS BEING USED ON THE PATIENTS' KNEE SINCE (B)(6) 2025. THE PATIENT FILLS THE UNIT TO THE MINIMUM LINE THE ICE CUBES. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE COULD NOT BE ESTABLISHED. IF ADDITIONAL INFORMATION REGARDING THIS REPORTED EVENT BECOMES AVAILABLE A SUPPLEMENTAL REPORT TO THIS DOCUMENT WILL BE SUBMITTED.