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Defibtech ARM XR Compression Module RMC-U2000Recalls & reported problems

Defibtech, L.L.C. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
3
Deaths reported
1
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00815098020812), received between Feb 17, 2026 and Sep 15, 2026 — classified as 1 death, 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 1 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

Device problems

  • Mechanical Problem2
  • Therapeutic or Diagnostic Output Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Insufficient Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 15, 2026Mechanical Problem

    A customer reported that their ARM ARM XR Engine RAM assembly sleeve slides downward when the piston starts its compression procedure and the device does not initiate compressions. The customer did not report this occurring during patient use.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50772432 ↗
  • DeathMar 30, 2026Therapeutic or Diagnostic Output Failure

    A PROFESSIONAL USER REPORTED THAT DURING A RESCUE ATTEMPT ON (B)(6) 2026 INVOLVING A PATIENT WHO HAD ATTEMPTED SUICIDE, THE ARM ACC DEVICE FUNCTIONED AS INTENDED UPON INITIAL PLACEMENT BUT CEASED PERFORMING CHEST COMPRESSIONS. THE CUSTOMER STATED THIS HAS OCCURRED DURING MULTIPLE RESCUE ATTEMPTS. RESPONDERS SOMETIMES ATTEMPTED TO READJUST THE PISTON, THOUGH NOT CONSISTENTLY. A BATTERY REPLACEMENT WAS ATTEMPTED BUT DID NOT RESOLVE THE ISSUE. THE CUSTOMER REPORTED MOTOR-RELATED WARNINGS IN THE DEVICE HISTORY. THEY ALSO NOTED THAT NO SERVICE INDICATOR LIGHT WAS PRESENT UPON POWER-ON, BUT THAT THE SERVICE INDICATOR MAY ILLUMINATE INTERMITTENTLY DURING USE.

    Patient problems: Insufficient Information

    MAUDE report 24719371 ↗
  • MalfunctionFeb 17, 2026Mechanical Problem

    A CUSTOMER REPORTED THAT THE SUCTION CUP OF THEIR ARM ACC UNIT WOULD NOT STAY ATTACHED TO THE PISTON DURING TESTING. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24372772 ↗

Other Compressor, Cardiac, External devices

All Compressor, Cardiac, External devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.