Defibtech ACC Compression Module RMC-A1000Recalls & reported problems
Defibtech, L.L.C. · Class 2
- Adverse event reports
- 16
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00815098020539), received between Feb 2, 2017 and Sep 25, 2026 — classified as 1 death, 15 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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.
Reports received per month
Most reported problems
Device problems
- Device Operates Differently Than Expected3
- Mechanical Problem2
- Adverse Event Without Identified Device or Use Problem1
- Battery Problem1
- Charging Problem1
- Complete Loss of Power1
- Device Stops Intermittently1
- Electrical /Electronic Property Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient5
- Death2
- No Patient Involvement1
- Unspecified Heart Problem1
- Wound Dehiscence1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Battery Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903620 ↗DeathMay 20, 2026Adverse Event Without Identified Device or Use Problem
A PROFESSIONAL CUSTOMER REPORTED AN ISSUE INVOLVING AN ACC ARM UNIT. THE CUSTOMER STATED THAT A PATIENT WAS FOUND UNCONSCIOUS ON THE BEDROOM FLOOR OF HER RESIDENCE. THE PATIENT HAD REPORTEDLY BEEN DOWN FOR APPROXIMATELY 15 MINUTES PRIOR TO THE INITIATION OF THERAPY. EMERGENCY MEDICAL SERVICES (EMS) APPLIED THE ARM UNIT TO THE PATIENT DURING RESUSCITATION EFFORTS. EMS REPORTED THAT THE DEVICE CAUSED A PENETRATING CHEST WOUND. THE PATIENT HAD A HISTORY OF OPEN-HEART SURGERY, AND IT APPEARED THAT THE PRIOR SURGICAL SCAR REOPENED DURING COMPRESSIONS. EMS ALSO REPORTED THAT THE PATIENT'S STERNUM WAS FRACTURED. DESPITE RESUSCITATION EFFORTS, THE PATIENT ULTIMATELY DID NOT SURVIVE. THE REPORTED CAUSE OF DEATH WAS ANOXIC BRAIN INJURY AND PROLONGED CARDIAC ARREST.
Patient problems: Wound Dehiscence
MAUDE report 25233807 ↗MalfunctionMar 17, 2026Failure to Advance
A CUSTOMER REPORTED THAT THEIR LIFELINE ARM WAS NOT COMPATIBLE WITH A REPLACEMENT BATTERY THEY HAD PURCHASED. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24620787 ↗MalfunctionMar 17, 2026Mechanical Jam
A CUSTOMER REPORTED THAT AFTER CLEANING THE ARM UNIT THEY FOUND THEY WERE UNABLE TO REMOVE THE COMPRESSIONS MODULE FROM THE FRAME. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24620778 ↗MalfunctionMar 17, 2026Fracture
A CUSTOMER REPORTED THEIR LIFELINE ARM HAS A SIGNIFICANT CRACK ALONG THE MIDPOINT OF THE FRAME. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24620777 ↗MalfunctionFeb 10, 2026Mechanical Problem
A PROFESSIONAL CUSTOMER REPORTED THAT THEIR ARM'S PISTON WOULD NOT LOWER DURING TESTING. THE CUSTOMER ALSO NOTED A RATTLE SOUND AND THAT THE ARM UNIT WAS FLASHING BOTH ITS WARNING AND SERVICE INDICATOR LIGHTS. THE CUSTOMER DID NOT REPORT THIS OCCURRING DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24308237 ↗MalfunctionFeb 3, 2026Loss of Power
A CUSTOMER REPORTED THEY RECEIVED THEIR ARM COMPRESSION UNIT BACK FROM A REPAIR CLAIM IN LATE DECEMBER AND AFTER JUST A COUPLE WEEKS OF USE, DURING TESTING THEIR ARM AUTOMATED CHEST COMPRESSION DEVICE POWERED ON BUT BEGAN BEEPING AND FLASHING IT'S WARNING INDICATOR BEFORE POWERING ITSELF OFF. THEY REPORTED THAT THIS DID NOT OCCUR DURING PATIENT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251290 ↗MalfunctionMay 11, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
DEFIBTECH WAS NOTIFIED OF A RESCUE ATTEMPT WHERE THE USER OF THE DEVICE REPORTED IT STOPPED PERFORMING COMPRESSIONS. THEY ALSO REPORTED THAT THE PATIENT WAS NOT RESUSCITATED. THE CUSTOMER PROVIDED AN EVENT SUMMARY FOR THE DEVICE WHICH SHOWED IT PERFORMED 200 COMPRESSIONS BEFORE THE DEVICE INDICATED LIMITATION IN ABILITY OF THE DEVICE TO PROPERLY MOVE. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.
Patient problems: Unspecified Heart Problem
MAUDE report 16915786 ↗MalfunctionNov 11, 2020Failure to Run on Battery; Failure to Run on Battery
AN EMERGENCY MEDICAL TRANSPORTATION COMPANY REPORTED THAT THEIR CHEST COMPRESSOR STOPPED COMPRESSIONS DURING A RESCUE ATTEMPT, AND THAT BOTH THE SERVICE AND WARNING LIGHTS WERE LIT. IT WAS ALSO REPORTED THAT THE PATIENT WAS NOT RESUSCITATED, AND NO ADDITIONAL EVENT OR DEVICE INFORMATION WAS PROVIDED. IT IS NOT KNOWN IF THE DEVICE WAS REMOVED AND IF MANUAL COMPRESSION WERE PERFORMED; THEREFORE, THIS MDR IS BEING SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. ALTHOUGH REQUESTED, THE DEVICE ASSOCIATED WITH THIS EVENT HAS NOT BEEN RETURNED AND THE CAUSE FOR THE EVENT IS NOT KNOWN.
Patient problems: Death
MAUDE report 10823935 ↗MalfunctionJun 28, 2019Mechanical Problem; Mechanical Problem
A CUSTOMER (A FIRE DEPARTMENT) REPORTED THAT WHEN THEY WENT TO USE THE DEVICE IN A RESCUE, THE WRENCH/SERVICE LIGHT AND WARNING LIGHT WERE ON AND THE DEVICE WOULD NOT PERFORM COMPRESSIONS. THEY WERE NOT SURE IF THERE WAS A DEATH OR SERIOUS INJURY RELATED TO THE EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8745432 ↗MalfunctionMay 29, 2019Charging Problem; Charging Problem
A CUSTOMER REPORTED A SQUEALING SOUND WHILE CHARGING THE COMPRESSION MODULE IN ITS CARRY BAG. THEY REPORTED THAT WHEN THEY OPENED THE CARRY BAG, THEY SAW SMOKE, BUT WERE NOT SURE IF THE CHARGER OR THE COMPRESSION MODULE WERE SMOKING. ALTHOUGH THIS DID NOT OCCUR DURING PATIENT USE AND THERE WAS NO PATIENT INVOLVEMENT, THIS MDR IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION.
Patient problems: No Patient Involvement
MAUDE report 8651419 ↗MalfunctionApr 12, 2019Complete Loss of Power; Complete Loss of Power
AN AMBULANCE COMPANY REPORTED THAT THE BATTERY STOPPED WORKING IN THE DEVICE DURING A RESCUE HOWEVER A SPARE BATTERY WAS USED, AND THEY WERE ABLE TO CONTINUE THE RESCUE. IT WAS NOT KNOWN IF THERE WAS A DEATH OR SERIOUS INJURY ASSOCIATED WITH THE EVENT AND NO ADDITIONAL EVENT OR PATIENT DETAILS WERE PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8511371 ↗MalfunctionOct 26, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED BY A PROFESSIONAL USER THAT THE DEVICE HAD ITS SERVICE AND WARNING INDICATORS LIT DURING USE. IT WAS ALSO REPORTED THAT ALTHOUGH THE PATIENT IN THIS CASE WAS NOT RESUSCITATED, THE PATIENT'S OUTCOME WAS NOT RELATED TO THE REPORTED DEVICE PROBLEM. NO OTHER PATIENT OR EVENT DETAILS WERE PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6980762 ↗MalfunctionAug 9, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THAT DURING A PATIENT RESCUE BY TWO PARAMEDICS AND EMTS, THE ACC FUNCTIONED NORMALLY FOR TEN MINUTES UNTIL IT WAS PAUSED SO THAT THE PATIENT COULD BE MOVED ONTO A STRETCHER. WHEN THE OPERATOR ATTEMPTED TO RESUME COMPRESSIONS, THE ACC WOULD NOT TURN ON. IT WAS REPORTED THAT THE PATIENT SURVIVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6776345 ↗MalfunctionJul 20, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
A FIRE DEPARTMENT REPORTED THAT THEY TRIED TO USE THE RMU-1000 IN A RESCUE ATTEMPT, BUT THE UNIT'S SERVICE LIGHT WAS FLASHING AND BEEPING. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6730247 ↗MalfunctionFeb 2, 2017Device Stops Intermittently
A PROFESSIONAL USER REPORTED THAT DURING TRANSPORT OF A FEMALE PATIENT FOUND UNRESPONSIVE IN THE SNOW, THE DEVICE STOPPED COMPRESSIONS AND THE UNIT INDICATED A PROBLEM. THE PROFESSIONAL USERS REPORTED THAT THEY ATTEMPTED TO TROUBLESHOOT THE DEVICE WHILE IT REMAINED ON THE PATIENT AS OPPOSED TO REMOVING IT AND PERFORMING MANUAL CHEST COMPRESSIONS, WHICH RESULTED IN CHEST COMPRESSIONS BEING DELAYED FOR APPROXIMATELY ONE MINUTE. AFTER SUCCESSFULLY TROUBLESHOOTING THE DEVICE, IT BEGAN PERFORMING COMPRESSIONS. THE PROFESSIONAL USER REPORTED THAT THE PATIENT WAS IN ASYSTOLE FROM THE BEGINNING OF THE EVENT AND WAS NOT RESUSCITATED. THE PROFESSIONAL USER FURTHER REPORTED THAT AFTER THE RESCUE, THEY OPERATED THE DEVICE ON A CPR DUMMY WITHOUT INCIDENT.
Patient problems: Death
MAUDE report 6298133 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.