LifeBand® Load-distributing Band Model 200 (REF 8700-001013)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00849111002981), received between Jun 5, 2024 and Sep 24, 2026 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Integrity Problem; Material Twisted/Bent; Material Split, Cut or Torn

  The customer reported that after a patient call, when the crew attempted to replace the AutoPulse NXT Band (LOT # 226137), they noticed the band's blue plastic belt had scrunched up. Based on the pictures provided by the customer, the band's Tyvek liner was torn, twisted, and jammed into the band guard. The AutoPulse NXT Platform itself turned on without any issues, displayed no error codes or messages, and functioned properly throughout the call. The damaged band remained in use throughout the entire call, and the crew discarded it afterward. No consequences or impact on the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50876680 ↗
• MalfunctionMar 14, 2026Use of Device Problem

  THE EVENT INVOLVED A 91-YEAR-OLD MALE (APPROX. 165 LBS) AT A PRIVATE RESIDENCE. THE CARDIAC ARREST WAS PRESUMED TO BE CARDIAC IN ORIGIN WITH NO OBSERVED SIGNS OF TRAUMA. THE ARREST WAS UNWITNESSED, WITH THE PATIENT LAST KNOWN CONSCIOUS APPROXIMATELY 30 MINUTES BEFORE DISCOVERY. NO BYSTANDER CPR WAS PERFORMED. UPON ARRIVAL, ANOTHER RESPONDING AGENCY PERFORMED MANUAL CPR FOR APPROXIMATELY 6 MINUTES BEFORE ATTEMPTING TO DEPLOY THE AUTOPULSE NXT PLATFORM. DURING DEPLOYMENT, THE PLATFORM (SN (B)(6) TOOK UP SLACK IN THE NXT BAND (LOT # 211084) BUT THEN STOPPED AND FAILED TO INITIATE COMPRESSIONS. FOLLOWING THE DEVICE FAILURE, THE CREW IMMEDIATELY TRANSITIONED BACK TO MANUAL CPR FOR APPROXIMATELY 12 MINUTES. ROSC WAS NOT ACHIEVED. THE PATIENT WAS PRONOUNCED DECEASED IN THE KITCHEN OF THE RESIDENCE BY AN EMERGENCY DEPARTMENT PHYSICIAN VIA TELEPHONE; THE CAUSE OF DEATH REMAINS UNKNOWN. NO DETRIMENTAL EFFECTS ATTRIBUTABLE TO THE NXT PLATFORM WERE IDENTIFIED. UPON RETURN TO THE STATION, THE EVENT LOG WAS DOWNLOADED VIA USB FROM THE NXT PLATFORM AND SHOWED FAULT 1210 (FAULT_MOTOR_SENSOR_LOW_DURING_COMPRES).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24600038 ↗
• MalfunctionFeb 2, 2026Material Integrity Problem; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT THE AUTOPULSE NXT BAND (LOT# UNKNOWN) FAILED BY SNAPPING DURING A CARDIAC ARREST EVENT. NO ADDITIONAL DEVICE FAILURES WERE REPORTED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 24229584 ↗
• MalfunctionJan 14, 2026Use of Device Problem

  THE RESPONDING CREW WAS INITIALLY DISPATCHED FOR AN UNCONSCIOUS PATIENT, A 37-YEAR-OLD MALE IN CARDIAC ARREST, DESCRIBED AS BEING OF AVERAGE HEIGHT AND WEIGHT. THE PATIENT HAD NO KNOWN MEDICAL HISTORY BUT REPORTEDLY HAD AN EXTENSIVE FAMILY HISTORY OF CARDIAC DISEASE. DURING THE RESPONSE, THE CREW ATTEMPTED TO DEPLOY THE AUTOPULSE NXT PLATFORM (SN: (B)(6). UPON PRESSING THE START BUTTON, THE NXT BAND (LOT#: UNKNOWN) WOULD BEGIN TIGHTENING, THEN RELEASE, AND THEN THE PLATFORM WOULD POWER OFF. THIS SEQUENCE OCCURRED TWO TO THREE TIMES. AFTER THE THIRD OCCURRENCE, THE CREW SUSPECTED A BATTERY-RELATED ISSUE AND ATTEMPTED TO REPLACE THE BATTERY. WHEN REMOVING THE AUTOPULSE NXT LI-ION BATTERY (SN: (B)(6) FROM THE NXT PLATFORM, THE D-RING ROTATED FREELY AND DID NOT RELEASE IMMEDIATELY. AFTER SEVERAL ATTEMPTS, THE D-RING ENGAGED, ALLOWING THE BATTERY TO BE REMOVED BY TURNING IT SLOWLY. THE BATTERY WAS PLACED ON A CHARGER, AND A REPLACEMENT NXT BATTERY WAS INSTALLED. THE AUTOPULSE NXT PLATFORM FUNCTIONED FOR SEVERAL MINUTES BEFORE SHUTTING OFF AGAIN. THIS BEHAVIOR RECURRED MULTIPLE TIMES DURING THE CALL, AFTER WHICH THE CREW TRANSITIONED TO MANUAL CPR. DESPITE THESE EFFORTS, THE PATIENT DID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24076490 ↗
• MalfunctionJan 6, 2026Material Integrity Problem; Material Split, Cut or Torn

  THE AUTOPULSE NXT PLATFORM (SN (B)(6) INITIALLY DELIVERED CHEST COMPRESSIONS TO THE PATIENT WITHIN 4-6 SECONDS BEFORE THE NXT BAND FAILURE. THE NXT BAND (LOT # UNKNOWN) RIPPED APART AT THE CLIP AND WAS DISCARDED. AFTER THE CREW INSTALLED THE NEW NXT BAND, THE DEVICE CONTRACTED AND RELEASED THE BAND BUT DID NOT DELIVER COMPRESSIONS. THE DEVICE DID NOT DISPLAY A FLASHING YELLOW TRIANGLE ALERT. THE CREW SWITCHED TO MANUAL CPR. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986086 ↗
• MalfunctionDec 4, 2025Fitting Problem; Material Integrity Problem; Material Split, Cut or Torn; Fitting Problem; Material Integrity Problem; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT THE CREW ATTEMPTED TO DEPLOY THE AUTOPULSE NXT PLATFORM (SN (B)(6) ON A PATIENT. THE CUSTOMER STATED THAT, TO THE BEST OF THEIR KNOWLEDGE, THE NXT BAND (LOT # UNKNOWN) WAS CORRECTLY ATTACHED TO THE NXT PLATFORM. UPON INITIAL INSPECTION, BOTH SIDES OF THE NXT BAND APPEARED TO BE IN GOOD WORKING CONDITION. THE NXT PLATFORM WAS USED ON A CONCRETE SURFACE, AND NO AUDIBLE ALERTS OR VISIBLE FAULTS WERE DISPLAYED ON THE CONTROL PANEL WHEN IT WAS POWERED ON. ACCORDING TO THE CUSTOMER, THE BAND INITIATED CORRECTLY; HOWEVER, SHORTLY THEREAFTER, THE BAND ON THE PATIENT'S RIGHT SIDE WENT SLACK. SIMULTANEOUSLY, THE LEFT-SIDE BAND SHIFTED AND BEGAN CONTRACTING IRREGULARLY, DELIVERING COMPRESSIONS SOLELY TO THE LEFT SIDE OF THE PATIENT'S CHEST. NO ONE ON SCENE NOTICED ANY WARNINGS OR LIGHTS ON THE PLATFORM'S CONTROL PANEL. THE USE OF THE NXT PLATFORM WAS DISCONTINUED, AND MANUAL CHEST COMPRESSIONS WERE INITIATED. THE CREW INSPECTED THE NXT PLATFORM AND ATTEMPTED TO REDEPLOY THE DEVICE, BUT THE SAME ISSUE OCCURRED. AFTER A THIRD UNSUCCESSFUL ATTEMPT, MANUAL COMPRESSIONS WERE CONTINUED FOR THE REMAINDER OF THE ENCOUNTER. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. THE CREW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23721394 ↗
• MalfunctionSep 9, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  THE CUSTOMER REPORTED THE AUTOPULSE NXT BAND (LOT UNKNOWN) SNAPPED RIGHT ABOVE THE PIN DURING USE. THE CREW REPLACED THE BAND AND WHEN DOING SO, THEY NOTICED THAT THE AUTOPULSE NXT PLATFORM (SN (B)(6) WAS VERY HOT. THEN SHORTLY AFTER, THE PLATFORM THREW A CODE. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 23006419 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED AN INCIDENT RECENTLY OCCURRED WITH THE AUTOPULSE NXT PLATFORM (SN UNKNOWN) AND AUTOPULSE NXT BAND (LOT UNKNOWN) WHERE A PATIENT WITH AN INCREASED BMI SUSTAINED SEVERE BL FLANK PRESSURE INJURIES SECONDARY TO THE STRAPS OF THE DEVICE. BECAUSE OF THE PATIENT'S INCREASED BMI, THE STRAPS WERE TOO TIGHT AROUND THEIR TRUNK CIRCUMFERENCE. DUE TO THIS, THE STRAPS DUG INTO THE PATIENT'S FLANKS CAUSING SEVERE DEGRADATION OF THE SKIN. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Skin Tears

  MAUDE report 22733600 ↗
• InjuryJul 9, 2025Use of Device Problem; Use of Device Problem

  A MALE PATIENT IN HIS LATE 20S (260 LB) SUFFERED CARDIAC ARREST DUE TO RESPIRATORY ARREST AND SUSPECTED BRONCHOSPASM, WITNESSED BY EMS ON SCENE. MANUAL CPR WAS INITIATED IMMEDIATELY AND CONTINUED FOR ABOUT 4 MINUTES BEFORE TRANSITIONING TO THE AUTOPULSE NXT PLATFORM (SN (B)(6), FOLLOWED BY EMERGENT TRANSPORT TO VCU HEALTH MEDICAL CENTER. THE NXT PLATFORM PERFORMED COMPRESSION FOR 23 MINUTES WITHOUT ISSUE DURING TRANSPORT, WITH NO OBSERVED SHIFTING OR NEED FOR THE NXT BAND ADJUSTMENT. HOWEVER, THE REPORTER WAS UNABLE TO VERIFY WHETHER ANY ADJUSTMENTS WERE MADE AFTER THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT. THE TRANSFER OF THE PATIENT TO THE TRAUMA BAY WAS ROUTINE AND OCCURRED WITHOUT ANY NOTEWORTHY EVENTS. APPROXIMATELY 10 MINUTES AFTER TURNOVER IN THE TRAUMA BAY OF THE MEDICAL CENTER, ER PROVIDERS HEARD A "SNAP" FROM THE NXT PLATFORM AND NOTED THE NXT BAND (LOT # 212884) WAS NO LONGER COMPRESSING. THEY CUT THE NXT BAND AWAY USING TRAUMA SHEARS, REMOVED THE NXT PLATFORM, AND PERFORMED MANUAL COMPRESSIONS UNTIL THEIR LUCAS DEVICE WAS DEPLOYED. DURING DEPLOYMENT OF THE LUCAS DEVICE, A DEEP SKIN LACERATION WAS OBSERVED ON THE PATIENT'S THORAX, BENEATH THE RIGHT ARMPIT.

  Patient problems: Laceration(s)

  MAUDE report 22465061 ↗
• MalfunctionJun 30, 2025Use of Device Problem; Use of Device Problem

  THE CUSTOMER INITIALLY REPORTED THAT THE AUTOPULSE NXT PLATFORM (SN (B)(6) DID NOT FUNCTION AS INTENDED DURING A PATIENT'S RESUSCITATION ATTEMPT. THE NXT PLATFORM FAILED TO PERFORM THE CPR MOTION WITH THE NXT BAND. THE CUSTOMER UTILIZED ANOTHER DEFIBRILLATOR TO RESUSCITATE THE PATIENT. UPON FOLLOWING UP, THE CUSTOMER REPORTED THAT WHEN ATTEMPTING TO INITIATE THE AUTOPULSE NXT PLATFORM, THE NXT BAND WAS UNABLE TO SIZE DOWN TO THE PATIENT'S CHEST BECAUSE AN INTERNAL WIRE THAT ADJUSTS THE BELT HAD BECOME COILED OR TWISTED, PREVENTING THE NXT BAND FROM LOWERING TO THE APPROPRIATE CHEST WIDTH. THE CUSTOMER STATED THAT THE COIL WAS INTERNAL, SO THERE WAS NO WAY FOR THE CUSTOMER TO UNTWIST IT AT THE BEDSIDE. AS A RESULT, THE NXT PLATFORM STARTED COMPRESSING WHILE VERY SLACK ON THE CHEST, NOT DELIVERING ADEQUATE COMPRESSIONS. THE CUSTOMER IMMEDIATELY STARTED MANUAL COMPRESSIONS WHEN THE NXT PLATFORM MALFUNCTIONED, SO THE CUSTOMER DOESN'T BELIEVE THERE WAS ANY SIGNIFICANT DELAY. NO CONSEQUENCES OR IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22359315 ↗
• MalfunctionJun 5, 2024Use of Device Problem; Use of Device Problem

  THE CREW DEPLOYED THE AUTOPULSE NXT PLATFORM (SN (B)(6) ) TO RESUSCITATE A 14-YEAR-OLD FEMALE CARDIAC ARREST PATIENT (WEIGHT - 250 LBS.). THE PATIENT RECEIVED 6 MINUTES OF MANUAL CPR BEFORE USING THE AUTOPULSE. BEFORE ARRIVING AT THE SCENE, THE CREW INSERTED THE NXT BAND AND SECURED IT CORRECTLY TO THE NXT PLATFORM. UPON ARRIVAL AT THE SCENE, THE CREW CUT THE PATIENT'S SHIRT UP THE CENTER TO START CPR AND LAID THE PATIENT ON THE NXT PLATFORM. THE NXT BAND WAS ALREADY ATTACHED TO THE NXT PLATFORM BEFORE THE PATIENT WAS LAID ON IT, AND THEN THE NXT BAND WAS PLACED ON THE PATIENT'S CHEST. THE COMPRESSIONS WERE INITIATED, AND THE CREW HAD TO STOP IT A COUPLE OF TIMES FOR OTHER REASONS. THE NXT PLATFORM PERFORMED COMPRESSIONS WITHOUT INTERRUPTIONS UNTIL THE CREW TRANSPORTED THE PATIENT TO THE HOSPITAL. AT THE HOSPITAL, THE ER CALLED THE CODE, AND THE PATIENT WAS PRONOUNCED DEAD BY THE PHYSICIAN. AFTER THE HOSPITAL ER CALLED THE CODE, THE CREW TRIED TO REMOVE THE NXT BAND AND COULD NOT DO SO. THE CREW HAD TO CUT THE NXT BAND, AND WHILE DOING THAT WAS WHEN THE CREW NOTICED THAT THE PATIENT'S SHIRT HAD WRAPPED AROUND THE NXT BAND'S PIN DURING COMPRESSIONS "(THE PATIENT'S SHIRT WAS SUCKED I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19468833 ↗