Summary: Defibtech, LLC, is recalling its RMU-2000 ARM XR Chest Compression Devices due to a motor issue that may cause the device to stop compressions, leading to potential patient injury or death.
Key Takeaways:
- The recall affects devices identified by specific serial numbers due to a malfunction in the motor that may stop chest compressions.
- Defibtech has reported one injury and one death related to the issue.
- Customers are advised to quarantine affected devices and await further instructions for return, repair, or replacement.
Defibtech, LLC, is recalling RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions.
Serious Health Risks Identified
The use of affected product may cause serious adverse health consequences, including patient injuries, delay of therapy, and death due to a period of time without compressions to circulate oxygen throughout the body.
There has been one reported injury and one report of death. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions.
Defibtech is telling customers to not use affected Defibtech RMU-2000 ARM XR Chest Compression Devices (identified by serial numbers).
Urgent Medical Device Safety Removal Notice
On July 12, 2024, Defibtech, LLC, sent all affected customers an Urgent Medical Device Safety Removal letter recommending the following actions:
- Identify and quarantine affected units.
- If devices were transferred or distributed further, please ensure the recipients are aware of this notice or provide Defibtech with contact information.
- Customers will be contacted by Defibtech to arrange for product return and devices will be refunded, repaired, or replaced at no cost.
Device Usage and Purpose
The RMU-2000 ARM XR Chest Compression Device is used to provide chest compressions on adults whose hearts suddenly stop and are not circulating blood throughout the body.
