Defibtech ARM XR Compression Module Configuration RMC-U2000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10815098020819), received between Apr 17, 2025 and Nov 20, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 12, 2024Open, Classified

   Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.

   Z-2543-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED THAT UPON ATTEMPTING TO REMOVE THE SUCTION CUP FROM THE PISTON OF THE AUTOMATED CARDIAC COMPRESSOR ARM THE COMPRESSION PITSON FELL OUT OF THE UNIT. THE CUSTOMER REPORTED THIS OCCURED AFTER A RESCUE ATTEMPT HOWEVER THEY REPORTED THE DEVICE OPERATED AS INTENDED DURING THE RESUCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611980 ↗
• MalfunctionNov 18, 2025Failure to Power Up; Failure to Power Up

  A CUSTOMER REPORTED THAT THEIR AUTOMATED CARDIAC COMPRESSOR ARM UNIT FAILED TO POWER ON WHEN THEY ATTEMPTED TO DEPLOY THE DEVICE DURING A RESCUE EVENT. NO PATIENT INJURY, OR OUTCOME INFORMATION WAS PROVIDED. THE CUSTOMER STATED THAT WHEN THE UNIT WAS LATER CONNECTED TO AN EXTERNAL POWER SUPPLY, THE DEVICE POWERED ON; HOWEVER, IT DID NOT INITIATE COMPRESSIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586903 ↗
• MalfunctionOct 30, 2025Crack; Crack

  THE ARM XR CHEST COMPRESSION DEVICE REPORTEDLY EXHIBITED FRAME CRACKING WHEN THE USER ATTEMPTED TO APPLY THE DEVICE TO THE PATIENT. THE UNIT COULD NOT BE SUCCESSFULLY APPLIED, AND THE RESPONDERS TRANSITIONED TO MANUAL CPR, RESULTING IN ROSC AND SURVIVAL TO HOSPITAL. ALTHOUGH THE EVENT OCCURRED DURING PATIENT TREATMENT, THERE IS NO EVIDENCE THAT THE DEVICE MALFUNCTION CONTRIBUTED TO OR COULD HAVE CAUSED DEATH OR SERIOUS INJURY, AS EFFECTIVE RESUSCITATION WAS ACHIEVED BY ALTERNATE MEANS. ACCORDINGLY, THIS EVENT DOES NOT MEET MDR REPORTABILITY CRITERIA AS AN ADVERSE EVENT UNDER 21 CFR 803.3. THE INCIDENT WILL BE SUBMITTED AS A PRODUCT PROBLEM MDR OUT OF AN ABUNDANCE OF CAUTION, DUE TO THE MECHANICAL DAMAGE(CRACKED FRAME) OBSERVED DURING ATTEMPTED USE.

  Patient problems: Insufficient Information

  MAUDE report 23429778 ↗
• MalfunctionJun 18, 2025Charging Problem; Charging Problem

  AN INTERNATIONAL DISTRIBUTOR REPORTED THAT THEIR CUSTOMER EXPERIENCED AN ISSUE WITH THE ARM DEVICE BATTERY. THE BATTERY WOULD NOT CHARGE, AND A CONTINUOUS FLASHING RED LIGHT WAS OBSERVED. ADDITIONALLY, THE DEVICE WOULD NOT POWER ON OR FUNCTION WHILE CONNECTED TO THE CHARGER. THE CUSTOMER CONFIRMED THAT THIS ISSUE DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287301 ↗
• MalfunctionApr 17, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED WHEN INSERTING THE LOCKING SLEEVE OF THE COMPRESSION MODULE INTO THE MODULE RECEPTACLE OF THE FRAME, THE COMPRESSION MODULE WOULD NOT LOCK INTO PLACE. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21860436 ↗
• MalfunctionApr 17, 2025Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED WHEN INSERTING THE LOCKING SLEEVE OF THE COMPRESSION MODULE INTO THE MODULE RECEPTACLE OF THE FRAME, THE COMPRESSION MODULE WOULD NOT LOCK INTO PLACE. THEY FURTHER REPORTED THE DAMAGE TO THE LOCKING SLEEVE. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859308 ↗
• MalfunctionApr 17, 2025Mechanical Problem; Mechanical Problem

  AN CUSTOMER REPORTED THEIR ARM BATTERY RELEASE BUTTON WILL NOT RETURN TO THE CORRECT POSITION. THEY FURTHER REPORTED THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21859097 ↗