Defibtech ACC Configuration RMC-E1000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10815098020628), received between Jan 12, 2018 and Nov 20, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Failure to Power Up; Failure to Power Up

  A CUSTOMER REPORTED THAT THEIR AUTOMATED CARDIAC COMPRESSOR ARM WILL NOT POWER ON BUT POWERED ON WITH A SPARE BATTERY PACK. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23612031 ↗
• MalfunctionApr 3, 2025Mechanical Problem; Failure to Power Up; Mechanical Problem; Failure to Power Up

  AN INTERNATIONAL DISTRIBUTOR REPORTED THAT THEIR ARM UNIT COULD NOT BE TURNED ON. THEY UNIT WAS TESTED WITH A KNOWN GOOD BATTERY AND WOULD STILL NOT POWER ON. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21763349 ↗
• MalfunctionFeb 7, 2025Device Alarm System; Mechanical Problem; Device Alarm System; Mechanical Problem

  AN INTERNATIONAL DISTRIBUTOR REPORTED UPON POWERING ON THE DEVICE DISPLAYED AN EXCLAMATION MARK ALARM AND COULD NOT BE USED. THE CUSTOMER REPORTED A WARNING OF "MOTOR DIDN'T MOVE IN TIME" FOUND IN THE HISTORY REPORT. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21338947 ↗
• MalfunctionJan 28, 2025Device Handling Problem; Device Handling Problem

  A CUSTOMER REPORTED AN ISSUE WITH THE ARM DEVICE NOT POWERING ON WHEN THE POWER BUTTON WAS PRESSED HOWEVER THE DEVICE POWERED ON WHEN ANOTHER NURSE HELD THE POWER BUTTON DOWN. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21257056 ↗
• MalfunctionDec 5, 2024Battery Problem; Battery Problem

  A CUSTOMER REPORTED THAT THEIR ACC ARM BATTERY WAS DEPLETED AND WILL NOT RETAIN A CHARGE. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20857207 ↗
• MalfunctionDec 4, 2024Mechanical Problem; Noise, Audible; Mechanical Problem; Noise, Audible

  A CUSTOMER REPORTED THAT DURING A CARDIAC ARREST, THE DEVICE MALFUNCTIONED DURING TRANSPORT AND WAS NOT ABLE TO BE RESTARTED AND THE DEVICE WAS BEEPING AND FLASHING. THEY ALSO REPORTED THAT RATTLING CAN BE HEARD FROM INSIDE THE COMPRESSION MODULE. THEY REPORTED THAT THE PATIENT WAS NOT RESUSCITATED.

  Patient problems: Insufficient Information

  MAUDE report 20847025 ↗
• MalfunctionNov 5, 2024Battery Problem; Battery Problem

  AN INTERNATIONAL DISTRIBUTOR REPORTED THEIR CUSTOMER'S UNIT COULD NOT CHARGE THE BATTERY PACK. THE CUSTOMER CHARGED BATTERY FOR 3 HOURS BUT THE BATTERY BAR STILL BLINKED RED ALL THE TIME AND SHOWED AN EXCLAMATION MARK. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20614792 ↗
• MalfunctionJun 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THE UNIT WILL SPORADICALLY ONLY PERFORM TWO (2) COMPRESSIONS AND WILL THEN STOP. IT WAS NOTED THAT THIS HAS HAPPENED BOTH IN TRAINING AND IN AN ACTUAL RESCUE.

  Patient problems: Unspecified Heart Problem

  MAUDE report 19638809 ↗
• MalfunctionMay 17, 2024Sparking; Unintended Electrical Shock; Sparking; Unintended Electrical Shock

  THE CUSTOMER REPORTED THAT WHEN THEY TOOK IT OUT THE ARM TO USE IT ON A PATIENT, IT WASN'T NEEDED SO THEY DECIDED TO DO SOME TRAINING. THEY REPORTED THAT THEY MAY HAVE FORCIBLY REMOVED OR PULLED ON THE CHARGING CABLE RESULTING IN DAMAGE TO THE CONNECTOR DUE TO THE POOR HANDLING BY THE STAFF. WHEN THEY PLUGGED IT IN, THE NURSE GOT A SHOCK. THE NURSE WAS UNINJURED AND NO ONE ELSE WAS INJURED. THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19346978 ↗
• MalfunctionFeb 15, 2024Mechanical Problem; Mechanical Problem

  A CUSTOMER REPORTED THAT WHEN THE RMU-1000 WAS TURNED ON, THERE WAS AN ALARM LIGHT A WARNING SOUND AND WOULD NOT FUNCTION.THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18717621 ↗
• MalfunctionJan 6, 2023Mechanical Problem; Mechanical Problem

  AN INTERNATIONAL DISTRIBUTOR REPORTED THAT WHEN A CUSTOMER WAS USING THE ARM WITH THE PATIENT, THE DEVICE STOPPED WORKING. NO PATIENT DETAILS WERE PROVIDED. THEY REPORTED THAT AFTER THE EVENT THEY CHECKED THE DEVICE'S REPORT AND FOUND THE FOLLOWING WARNINGS: "WARN - MOTOR SHOULD BE HOME" AND "WARN - MOTOR DIDN'T MOVE IN TIME".

  Patient problems: Unspecified Heart Problem

  MAUDE report 16117472 ↗
• MalfunctionDec 15, 2022Mechanical Problem; Mechanical Problem

  AN INTERNATIONAL DISTRIBUTOR RELAYED A REPORT FROM A PROFESSIONAL USER THAT THE COMPRESSION DEVICE STOPPED PERFORMING COMPRESSIONS DURING USE. IT WAS ALSO REPORTED THAT THERE WAS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THE REPORTED DEVICE PROBLEM. NO OTHER PATIENT OR EVENT DETAILS WERE PROVIDED.

  Patient problems: Cardiac Arrest

  MAUDE report 15986500 ↗
• InjuryJan 12, 2018Therapy Delivered to Incorrect Body Area; Therapy Delivered to Incorrect Body Area

  ON (B)(6) 2017, IT WAS REPORTED BY AN INTERNATIONAL DISTRIBUTOR THAT THE DEVICE WAS USED ON A FEMALE PATIENT WHO ARRIVED IN CARDIAC ARREST OR ARRESTED SHORTLY AFTER ARRIVING TO HOSPITAL, SUFFERED A MASSIVE PULMONARY EMBOLISM AND DIED. THEY ALSO REPORTED THAT DURING THE RESCUE THE DEVICE MIGRATED SOUTH ON THE PATIENT AND A POST MORTEM OF THE PATIENT IDENTIFIED DAMAGE TO THE LIVER AND SPLEEN; HOWEVER, THE DOCTORS WERE UNSURE WHETHER THE INJURY WAS RELATED TO THE DEVICE OR WHETHER THE PATIENT HAD BEEN ASSAULTED. ON JANUARY 11, 2018, THE INTERNATIONAL DISTRIBUTER REPORTED THAT THE MEDICAL CONSULTANT IN THIS CASE, AN MD, AGREED THAT THERE WERE OTHER COMPLICATIONS WITH THE PATIENT AND THEY WERE NOT ATTRIBUTING HER DEATH TO THE USE OF THE RMU-1000. HOWEVER, THEY REPORTED THAT ALTHOUGH THE RMU-1000'S STABILIZATION STRAP WAS PROVIDED, THE CUSTOMER STATED THAT IT WASN'T USED IN THIS INSTANCE.

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 7187911 ↗