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Intellectual & Developmental Disabilities

The Office of Developmental Programs (ODP) has shared this important announcement from the U.S. Food and Drug Administration (FDA) about the recall of Defibtech, LLC, RMU-2000 ARM XR Chest Compression Devices due to a problem with the device’s motor that may cause it to stop compressions. The use of the 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.

This recall involves removing certain devices from where they are used or sold. 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.

Affected Product

  • RMU-2000 Chest Compression Module
    • Product Name: RMU-2000 ARM XR Chest Compression Device
    • Unique Device Identifier (UDI)/: UDI-DI: 00815098020812, 10815098020819
    • Serial Numbers: See full list.

What to Do

Do not use affected Defibtech RMU-2000 ARM XR Chest Compression Devices (identified by serial numbers). 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; and
  • 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.

Reason for Recall

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.

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.

Device Use

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.

Contact Information

Customers in the US with questions about this recall should contact Defibtech Customer Support at 877-453-4507, 7:30 am – 6:00 pm EST.

This is a final reminder that early bird rates for the 2024 RCPA Conference Embracing Challenges, Empowering Success end this Friday, August 23! View our registration brochure for complete details, including Connections Hall networking opportunities, plenary and keynote speakers, and booking your hotel room at the Hershey Lodge. Please be aware that conference hotel rates end August 30, 2024. You can also visit our Conference website for the latest information.

Register Here for the 2024 RCPA Conference

Contact Carol Ferenz, Conference Coordinator, with any questions. We look forward to seeing you at the Hershey Lodge!

The Technology Accelerator Project is looking for providers to partner in developing a new Change Readiness Tool. Shea Tanis will be coordinating several provider readiness focus groups, which will lead to the development of a Change Readiness Tool to support the successful adoption of remote support/monitoring and assistive technology solutions for providers statewide.

The project is looking for providers across Pennsylvania to join them for a 90-minute virtual session to discuss promising practices, human and fiscal resources, existing policies, implementation barriers, and agency needs to adapt and employ remote supports/monitoring and assistive technologies.

View the flyer for additional information and how to get involved with this project. Contact Carol Ferenz with any questions.

The Office of Developmental Programs (ODP) has shared ODPANN 24-080. This communication announces that Temple University Harrisburg’s Certified Investigator (CI) Program and ODP will be facilitating forums for certified investigators and others involved in the incident investigation process. It also announces the posting of Q&A documents from past CI Forums on MyODP. Please view the announcement for registration information and details.

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