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Defibtech ACC Configuration RMC-A1000Recalls & reported problems

Defibtech, L.L.C. · Class 2

All models of Defibtech ACC Configuration (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Defibtech ARM automated chest compression unit is a cardiac compressor that delivers chest compressions during cardiac arrest. The 67 reports mostly describe the device failing to power on, not charging, or stopping mid-rescue with warning lights flashing and the piston not lowering; several note the battery pack was expired or would not charge. Reports describe 1 death and 2 injuries. There are no recalls naming this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
67
Deaths reported
1
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10815098020536), received between Jun 2, 2017 and Dec 10, 2025 — classified as 1 death, 2 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (23 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 2 reportsFeb 2024: 4 reportsMar 2024: 2 reportsApr 2024: 2 reportsMay 2024: 1 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 2 reportsSep 2024: 4 reportsOct 2024: 2 reportsNov 2024: 3 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 2 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 4 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 2 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem23
  • Failure to Power Up8
  • Insufficient Device Problem Information7
  • Battery Problem5
  • Failure to Charge4
  • Activation, Positioning or Separation Problem3
  • Device Operates Differently Than Expected3
  • Electrical /Electronic Property Problem2

Patient problems

  • Insufficient Information25
  • No Clinical Signs, Symptoms or Conditions23
  • Unspecified Heart Problem6
  • No Known Impact Or Consequence To Patient5
  • Cardiac Arrest3
  • Death2
  • Injury1
  • No Information1

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 10, 2025Battery Problem; Battery Problem

    A CUSTOMER REPORTED THAT DURING PREPARATION FOR A RESCUE, THEIR ARM AUTOMATED CHEST COMPRESSION DEVICE WOULD NOT POWER ON WHEN DISCONNECTED FROM THE CHARGING CABLE. THE BATTERY PACK WAS LATER CONFIRMED TO BE EXPIRED. THE ISSUE WAS IDENTIFIED BEFORE THE ARM WAS APPLIED, AND MANUAL CPR WAS PERFORMED. NO ADDITIONAL RESCUE DETAILS OR PATIENT OUTCOME INFORMATION WERE AVAILABLE, AS THE RESPONDER INVOLVED IS NO LONGER WITH THE COMPANY AND CANNOT BE CONTACTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23773877 ↗
  • MalfunctionDec 5, 2025Activation Problem; Activation Problem

    AN INTERNATIONAL DISTRIBUTOR REPORTED THAT THEIR CUSTOMER'S ARM AUTOMATED CHEST COMPRESSION UNIT WAS INOPERABLE. WHEN POWERING ON, IT DISPLAYED AN ALARM INDICATED BY THE EXCLAMATION MARK SYMBOL. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23728517 ↗
  • MalfunctionNov 20, 2025Mechanical Problem; Mechanical Problem

    A CUSTOMER REPORTED PRIOR TO A RESCUE ATTEMPT THEIR AUTOMATED CARDIAC COMPRESSOR ARM UNIT BEGAN FLASHING ITS WARNING INDICATOR AND THE PISTON WOULD NOT LOWER. THE ARM WAS NOT USED DURING THE RESCUE ATTEMPT; THE FAILURE WAS IDENTIFIED PRIOR TO THE RESCUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23612070 ↗
  • MalfunctionOct 30, 2025Activation, Positioning or Separation Problem; Power Problem; Activation, Positioning or Separation Problem; Power Problem

    A PROFESSIONAL CUSTOMER REPORTED THAT DURING A RESCUE ATTEMPT, THE ARM UNIT UNEXPECTEDLY STOPPED DELIVERING CHEST COMPRESSIONS. THE DEVICE'S WARNING AND SERVICE INDICATOR LIGHTS BEGAN FLASHING. THE CUSTOMER SUBSEQUENTLY POWERED THE UNIT OFF; HOWEVER, THEY WERE UNABLE TO POWER THE UNIT BACK ON.

    Patient problems: Insufficient Information

    MAUDE report 23429777 ↗
  • MalfunctionSep 18, 2025Failure to Power Up; Failure to Power Up

    A CUSTOMER REPORTED THEIR ARM AUTOMATED CHEST COMPRESSION DEVICE WOULD NOT POWER ONE. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23083853 ↗
  • MalfunctionSep 3, 2025Failure to Advance; Failure to Advance

    A PROFESSIONAL CUSTOMER REPORTED THAT THEIR ARM UNIT'S PISTON FAILED TO FULLY LOWER DURING A RESCUE ATTEMPT. NO PATIENT IMPACT OR OUTCOME WAS REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 22953542 ↗
  • MalfunctionJul 22, 2025Battery Problem; Battery Problem

    A CUSTOMER REPORTED THEIR ARM BATTERY WILL NOT CHARGE OR POWER ON. THEY REPORTED THAT THIS BATTERY PACK HAS BEVER BEEN USED. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22569529 ↗
  • MalfunctionJul 14, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

    A PROFESSIONAL CUSTOMER REPORTED THAT WHILE RESPONDING TO A PATIENT IN CARDIAC ARREST, THE ARM (AUTOMATED CHEST COMPRESSOR) UNIT WAS PAUSED TO REPOSITION THE PISTON FOR IMPROVED COMPRESSION ALIGNMENT. HOWEVER, AFTER REPOSITIONING THE PISTON, THE DEVICE WOULD NOT RESUME COMPRESSIONS AS EXPECTED. AS A RESULT, THE ARM UNIT WAS REMOVED FROM THE PATIENT, AND MANUAL CPR WAS INITIATED.

    Patient problems: Insufficient Information

    MAUDE report 22497092 ↗
  • MalfunctionJun 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    A CUSTOMER REPORTED THAT DURING A RESCUE ATTEMPT, THEIR ARM UNIT DELIVERED TWO COMPRESSIONS BEFORE STOPPING AND ACTIVATING BOTH THE WARNING AND SERVICE INDICATOR LIGHTS. NO ADDITIONAL EVENT DETAILS OR PATIENT INFORMATION WERE PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22350035 ↗
  • MalfunctionJun 18, 2025Connection Problem; Connection Problem

    A CUSTOMER REPORTED THAT DURING A RESCUE ATTEMPT, THE ARM DEVICE'S PISTON MODULE WOULD NOT LOWER TO THE PATIENT'S CHEST. AT THE TIME OF THE ISSUE, ONLY ONE GREEN INDICATOR LIGHT WAS FLASHING. SHORTLY THEREAFTER, ALL INDICATOR LIGHTS TURNED OFF. THE EXACT DATE OF THE EVENT WAS NOT KNOWN. THE RESCUE TEAM REPORTED THAT THE PATIENT SURVIVED TRANSPORT TO THE HOSPITAL BUT UNFORTUNATELY DID NOT SURVIVE TO DISCHARGE.

    Patient problems: Insufficient Information

    MAUDE report 22287924 ↗
  • MalfunctionJun 17, 2025Premature Discharge of Battery; Premature Discharge of Battery

    A CUSTOMER REPORTED THAT THEIR ARM DEVICE FAILED TO POWER ON DURING A RESCUE ATTEMPT. RESCUE PERSONNEL ATTEMPTED TO REPLACE THE BATTERY PACK; HOWEVER, THE DEVICE STILL DID NOT POWER ON AFTER THE REPLACEMENT. CPR WAS ADMINISTERED, BUT THE PATIENT WAS NOT RESUSCITATED.

    Patient problems: Insufficient Information

    MAUDE report 22244047 ↗
  • MalfunctionJun 3, 2025Mechanical Problem; Mechanical Problem

    A CUSTOMER REPORTED THAT DURING A RESCUE ATTEMPT, THEIR ARM DEVICE CEASED DELIVERING CHEST COMPRESSIONS AND BEGAN FLASHING A WARNING INDICATOR. IN RESPONSE, THE DEVICE WAS REMOVED FROM THE PATIENT AND MANUAL CPR WAS INITIATED. THE PATIENT WAS NOT RESUSCITATED. FOLLOWING THE EVENT, THE CUSTOMER CONDUCTED FUNCTIONAL TESTING USING A MANIKIN. DURING TESTING, IT WAS OBSERVED THAT THE DEVICE'S PISTON FAILED TO ADJUST DOWNWARD TO CONTACT THE MANIKIN'S CHEST, THEREBY PREVENTING THE INITIATION OF COMPRESSIONS.

    Patient problems: Insufficient Information

    MAUDE report 22137021 ↗
  • MalfunctionMay 23, 2025Failure to Cycle; Failure to Cycle

    A PROFESSIONAL CUSTOMER REPORTED THAT DURING A PATIENT RESCUE EVENT, THE AUTOMATED RESUSCITATION MACHINE (ARM) UNIT UNEXPECTEDLY CEASED CHEST COMPRESSIONS AND BEGAN FLASHING A BATTERY WARNING INDICATOR. TO THE CREW USING THE DEVICE, IT APPEARED AS THOUGH THE UNIT HAD OVERHEATED AND SHUT DOWN. AFTER THE RESCUE, THE BATTERY WAS REMOVED AND REINSTALLED, AT WHICH POINT THE DEVICE RESUMED NORMAL OPERATION, AND THE BATTERY APPEARED TO BE FUNCTIONING NORMALLY. NO PATIENT HARM WAS REPORTED IN ASSOCIATION WITH THIS EVENT.

    Patient problems: Insufficient Information

    MAUDE report 22079947 ↗
  • MalfunctionMay 23, 2025Mechanical Problem; Mechanical Problem

    A CUSTOMER REPORTED THAT THEIR ARM UNIT WOULD NOT PERFORM COMPRESSIONS DURING A RESCUE ATTEMPT, AND MANUAL CPR WAS PERFORMED. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT RESUSCITATED.

    Patient problems: Insufficient Information

    MAUDE report 22079926 ↗
  • MalfunctionMar 18, 2025Failure to Advance; Failure to Advance

    A CUSTOMER REPORTED DURING A RESCUE ATTEMPT THEIR ARM UNIT FAILED TO LOWER PROPERLY TO THE PATIENT'S CHEST, AND THE SERVICE LIGHT BEGAN FLASHING.

    Patient problems: Insufficient Information

    MAUDE report 21635510 ↗
  • MalfunctionFeb 20, 2025Failure to Charge; Failure to Charge

    THE CUSTOMER REPORTED THAT THE AUTOMATED COMPRESSION ARM FAILED TO CHARGE ITS BATTERY PACK, RENDERING THE DEVICE INOPERABLE. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21426824 ↗
  • MalfunctionFeb 20, 2025Failure to Charge; Battery Problem; Failure to Charge; Battery Problem

    A CUSTOMER REPORTED THEIR ARM BATTERY WILL NOT CHARGE OR POWER THE UNIT. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21426820 ↗
  • MalfunctionNov 22, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    A CUSTOMER REPORTED AN ISSUE WITH THE ARM UNIT DURING A CARDIAC ARREST RESCUE. THEY STATED THAT THE UNIT PERFORMED 2-3 COMPRESSIONS BEFORE STOPPING AND TRIGGERING AN ALARM, DESPITE THE BATTERY INDICATING A FULL CHARGE. THEY ATTEMPTED TO TROUBLESHOOT THE DEVICE BUT ULTIMATELY REMOVED IT AND TRANSITIONED TO MANUAL CPR. AFTER THE RESCUE, THE CUSTOMER TESTED THE UNIT, AND IT OPERATED WITHOUT ISSUE.

    Patient problems: Insufficient Information

    MAUDE report 20763237 ↗
  • MalfunctionNov 20, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

    IT WAS REPORTED BY A CUSTOMER THAT DURING A RESCUE ATTEMPT, THE DEVICE STOPPED COMPRESSIONS. THEY REPORTED THAT THEY TRIED REPLACING THE BATTERY PACK DURING THE RESCUE ATTEMPT, BUT THE ISSUE CONTINUED. THEY FURTHER REPORTED THAT THE PATIENT WAS NOT RESUSCITATED.

    Patient problems: Insufficient Information

    MAUDE report 20738647 ↗
  • MalfunctionNov 14, 2024Failure to Power Up; Failure to Power Up

    A CUSTOMER REPORTED THAT DURING A RESUSCITATION ATTEMPT ON A FEMALE PATIENT THAT HAD BEEN DOWN FOR APPROXIMATELY AN HOUR, THE DEVICE PERFORMED COMPRESSIONS FOR TWO MINUTES THEN IT STOPPED AND COULD NOT BE RESET OR RESTARTED. THE CUSTOMER REPORTED THAT THE DEVICE WAS REMOVED, AND MANUAL CPR WAS IMMEDIATELY STARTED.

    Patient problems: Insufficient Information

    MAUDE report 20689359 ↗
  • MalfunctionOct 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    THE CUSTOMER REPORTED THAT DURING USE ON A PATIENT THE DEVICE WAS POWERED ON, AND PISTON LOWERED 1BINCH AND THEN THE DEVICE POWERED OFF. THEY REPORTED THAT CPR WAS PERFORMED AND THAT THE PATIENT SURVIVED TO HOSPITAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20466200 ↗
  • MalfunctionOct 10, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

    THE CUSTOMER REPORTED THAT THE UNIT PERFORMED UP TO 5 COMPRESSIONS DURING THE RESCUE, THEN POWERED OFF. THEY STATED THAT THE UNIT BEEPED WHEN FIRST POWERED ON, WITH THE WARNING INDICATOR FLASHING. AFTER A SHORT TIME, THE UNIT BEGAN COMPRESSIONS, THEN PAUSED BRIEFLY BEFORE RESTARTING COMPRESSIONS WITHOUT ANY WARNING INDICATOR OR SERVICE LIGHT ON. THEY REPORTED THAT RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED, AND THE PATIENT SURVIVED TO HOSPITAL.

    Patient problems: Insufficient Information

    MAUDE report 20423684 ↗
  • MalfunctionSep 27, 2024Failure to Power Up; Failure to Power Up

    THE CUSTOMER REPORTED THAT THEIR ARM WILL NO LONGER WORK. THE CUSTOMER SAID THAT THE ARM HAS BEEN OUT OF SERVICE FOR 6+ MONTHS. THE SERVICE/SOFTWARE WAS UPGRADE- UNIT NOT AVAILABLE FOR TROUBLE SHOOTING AT TIME OF CALL. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20322276 ↗
  • MalfunctionSep 19, 2024Failure to Power Up; Failure to Power Up

    THE CUSTOMER REPORTED THAT WHEN RESPONDING TO A PATIENT INVOLVED IN A CAR ACCIDENT, THE CHEST COMPRESSOR WOULD NOT POWER ON OR PERFORM COMPRESSIONS. THE CUSTOMER STATED THAT THEY TRIED TO TURN ON THE ARM; IT RESPONDED BUT COULD NOT LOWER THE PISTON TO THE PATIENT'S CHEST. THEY ATTEMPTED THIS A TOTAL OF THREE TIMES, BUT THE ARM SHUT OFF EACH TIME. IT WAS REPORTED THAT THE PATIENT DID NOT SURVIVE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20257384 ↗
  • MalfunctionSep 5, 2024Mechanical Problem; Mechanical Problem

    THE CUSTOMER REPORTED THAT THE ARM GIVING AN AUDIBLE ALARM AND RED SERVICE INDICATOR LIGHT. THE COMPRESSION PISTON WILL ALSO NOT LOWER. THE CUSTOMER DID NOT REPORT THIS EVENT OCCURRED DURING PATIENT USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20148323 ↗

Other Compressor, Cardiac, External devices

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Sources and updates

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