LifeBand® Load-distributing Band 100 (REF 8700-0701-08)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00849111001588), received between Mar 9, 2020 and Apr 18, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K112998); they may or may not involve this specific model.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN: (B)(6) OPERATED WITHOUT ISSUES FOR ABOUT 20 MINUTES BEFORE THE LIFEBAND (LOT#: 197739) UNEXPECTEDLY TORE OFF. SUBSEQUENTLY, AN ERROR MESSAGE APPEARED ON THE PLATFORM. THE CUSTOMER MENTIONED THAT THE DISPLAY SCREEN'S LIGHT WAS DEFECTIVE (DARK) BUT STILL READABLE. HOWEVER, THEY COULDN'T RECALL THE ERROR CODE DISPLAYED ON THE LCD SCREEN. THE TORN LIFEBAND WAS CONTAMINATED WITH THE PATIENT'S BODILY FLUIDS AND NEEDED TO BE DISPOSED OF. THE ISSUE OCCURRED ON THE WAY TO THE DESTINATION HOSPITAL, AND THE CREW IMMEDIATELY CONTINUED MANUAL RESUSCITATION. RESUSCITATION WAS BRIEFLY INTERRUPTED TO UNLOAD THE STRETCHER FROM THE AMBULANCE. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. AFTER THE CALL, THE CUSTOMER ATTEMPTED TO PUT THE AUTOPULSE PLATFORM BACK INTO OPERATION. TO DO THIS, THEY HAD TO REMOVE THE REMAINS OF THE TORN LIFEBAND FROM THE SHAFT. THE CUSTOMER STATED THAT THE LIFEBAND HAD APPARENTLY TORN ON THE SHAFT OF THE PLATFORM, WHERE THE BAND IS SEWN AND GLUED. THE ADHESIVE ON THE LIFEBAND'S BLACK HINGED BELT GUARDS (SKIRTS) THAT ARE THREADED INTO THE SHAFT WAS NO LONGER IN GOOD CONDITION, AND THE SEAM COULD NOT WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867995 ↗
• MalfunctionJul 3, 2024Loose or Intermittent Connection; Retraction Problem; Loose or Intermittent Connection; Retraction Problem

  WHEN THE CUSTOMER FIRST INSTALLED THE LIFEBAND (LOT #UNKNOWN) ON THE AUTOPULSE PLATFORM FOR PATIENT USE, THE LIFEBAND BECAME LOOSE AND DID NOT RETRACT PROPERLY. THE PATIENT WAS SUPPOSEDLY POSITIONED CORRECTLY. THE CUSTOMER DOES NOT KNOW WHICH ERROR MESSAGE HAS OCCURRED. THE CUSTOMER DISCARDED THE LIFEBAND AND SWITCHED TO MANUAL CPR. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE. THE CUSTOMER'S BIOMEDICAL ENGINEER INSPECTED THE AUTOPULSE PLATFORM USED AT THE TIME OF THE EVENT BUT DID NOT FIND ANY ISSUES WITH THE PLATFORM. THE BIOMEDICAL ENGINEER TESTED THE AUTOPULSE PLATFORM WITH ANOTHER LIFEBAND, BUT THE ISSUE WAS NOT REPLICATED.

  Patient problems: Insufficient Information

  MAUDE report 19667919 ↗
• MalfunctionApr 3, 2023Use of Device Problem; Use of Device Problem

  THE AUTOPULSE PLATFORM (SN (B)(4)) WAS USED IN THE NON-TRAUMATIC SHOCK ROOM TO RESUSCITATE A MALE PATIENT IN CARDIAC ARREST. THE ONGOING RESUSCITATION WAS IN PLACE BEFORE THE PLATFORM USE. THE PLATFORM STOPPED AFTER PERFORMING 3 COMPRESSIONS. THE PLATFORM WAS RESTARTED, HOWEVER, THE CUSTOMER WAS NOT ABLE TO RESOLVE THE ISSUE AND THE PLATFORM STOPPED AGAIN AFTER PERFORMING 3 COMPRESSIONS. THE LUCAS DEVICE WAS USED FROM THE CATHETER LAB TO CONTINUE CPR. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE. DURING THE TROUBLESHOOTING OF THE PLATFORM, THE BELT COVER OF THE LIFEBAND (LOT# 179342) WAS OBSERVED TORN AND HAD DISRUPTED OPERATION SINCE IT HAD DAMAGE. PER THE REPORTER, THE AUTOPULSE BATTERY WAS REPLACED AND THE LIFEBAND WAS EXAMINED DURING THE MORNING SHIFT CHECK. THE LIFEBAND WAS NOTED IN GOOD CONDITION. PLEASE SEE THE FOLLOWING RELATED MFR REPORTS: MFR 3010617000-2023-00317 FOR AUTOPULSE PLATFORM (SN (B)(4)).

  Patient problems: Insufficient Information

  MAUDE report 16661317 ↗
• MalfunctionJan 27, 2022Use of Device Problem; Use of Device Problem

  A 48-YEAR-OLD MALE PATIENT WITH SIGNIFICANT CORONARY ARTERY DISEASE WENT INTO CARDIAC ARREST DURING A RESCUE ANGIOPLASTY PROCEDURE. THE HOSPITAL LAB STAFF DEPLOYED THE AUTOPULSE PLATFORM ((B)(6)). THE STAFF ROLLED THE PATIENT ONTO THE AUTOPULSE PLATFORM BUT WAS INCORRECTLY POSITIONED, AND AS A RESULT, THE AUTOPULSE FAILED TO PERFORM COMPRESSION. IMMEDIATELY, THE STAFF REMOVED THE AUTOPULSE AND PERFORMED MANUAL CPR. THE STAFF NOTED THAT LIFEBAND #1 (LOT #151223) GOT DAMAGED AND WAS REMOVED AND REPLACED. AFTER REPLACING THE DAMAGED LIFEBAND, THE AUTOPULSE PLATFORM WAS REDEPLOYED WITH LIFEBAND #2 (LOT #151223) PLACED ACROSS THE PATIENT'S CHEST AT THE HEART LEVEL WITH DIRECT SKIN CONTACT. THE AUTOPULSE POWERED ON AND FAILED TO INITIATE CHEST COMPRESSIONS WITH THE ERROR MESSAGE "PATIENT INCORRECTLY ALIGNED." THE STAFF TRIED TO TROUBLESHOOT MULTIPLE TIMES BY RESETTING THE LIFEBAND, CHECKING PATIENT ALIGNMENT, REBOOTING THE AUTOPULSE, AND REPLACING THE LI-ION BATTERY; HOWEVER, THE ISSUE PERSISTED. THE STAFF PERFORMED MANUAL CPR IN BETWEEN THE TROUBLESHOOTING ATTEMPTS. THE CUSTOMER STATED THAT ON A FEW OCCASIONS DURING THE EVENT, THE AUTOPULSE PLATFORM PERFORMS ONE COMPRESSION AND PROMPTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13374988 ↗
• MalfunctionJan 27, 2022Use of Device Problem; Use of Device Problem

  A (B)(6)-YEAR-OLD MALE PATIENT WITH SIGNIFICANT CORONARY ARTERY DISEASE WENT INTO CARDIAC ARREST DURING A RESCUE ANGIOPLASTY PROCEDURE. THE HOSPITAL LAB STAFF DEPLOYED THE AUTOPULSE PLATFORM (SN (B)(4)). THE STAFF ROLLED THE PATIENT ONTO THE AUTOPULSE PLATFORM BUT WAS INCORRECTLY POSITIONED, AND AS A RESULT, THE AUTOPULSE FAILED TO PERFORM COMPRESSION. IMMEDIATELY, THE STAFF REMOVED THE AUTOPULSE AND PERFORMED MANUAL CPR. THE STAFF NOTED THAT LIFEBAND #1 (LOT #UNKNOWN) GOT DAMAGED AND WAS REMOVED AND REPLACED. AFTER REPLACING THE DAMAGED LIFEBAND, THE AUTOPULSE PLATFORM WAS REDEPLOYED WITH LIFEBAND #2 (LOT #UNKNOWN) PLACED ACROSS THE PATIENT'S CHEST AT THE HEART LEVEL WITH DIRECT SKIN CONTACT. THE AUTOPULSE POWERED ON AND FAILED TO INITIATE CHEST COMPRESSIONS WITH THE ERROR MESSAGE "PATIENT INCORRECTLY ALIGNED." THE STAFF TRIED TO TROUBLESHOOT MULTIPLE TIMES BY RESETTING THE LIFEBAND, CHECKING PATIENT ALIGNMENT, REBOOTING THE AUTOPULSE, AND REPLACING THE LI-ION BATTERY; HOWEVER, THE ISSUE PERSISTED. THE STAFF PERFORMED MANUAL CPR IN BETWEEN THE TROUBLESHOOTING ATTEMPTS. THE CUSTOMER STATED THAT ON A FEW OCCASIONS DURING THE EVENT, THE AUTOPULSE PLATFORM PERFORMS ONE COMPRESSION AND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13374845 ↗
• MalfunctionFeb 23, 2021Retraction Problem; Retraction Problem

  DURING PATIENT USE, THE LIFEBAND (LOT # UNKNOWN) WAS UNABLE TO BE RETRACTED ON THE AUTOPULSE PLATFORM (SN: (B)(4)). IN ADDITION, THE LCD SCREEN OF THE PLATFORM WAS REPORTED TO BE DEFECTIVE. NO FURTHER INFORMATION OR CLARIFICATION WAS PROVIDED BY THE CUSTOMER. PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE; THEREFORE, PATIENT'S STATUS IS UNKNOWN. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021-00147 FOR THE AUTOPULSE PLATFORM (SN: (B)(4)).

  Patient problems: Insufficient Information

  MAUDE report 11369868 ↗
• MalfunctionFeb 12, 2021Use of Device Problem; Use of Device Problem

  AS REPORTED, THE LIFEBAND (LOT # UNKNOWN) WAS UNABLE TO BE RETRACTED ON THE AUTOPULSE PLATFORM (SN: (B)(4)). IN ADDITION, ONE OF THE HEAD RESTRAINT WIRES WAS NOTED TO BE TORN OFF. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER. PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED; THEREFORE, PATIENT USE IS UNKNOWN. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2021-00117 FOR THE AUTOPULSE PLATFORM (SN: (B)(4)).

  Patient problems: Insufficient Information

  MAUDE report 11325116 ↗
• MalfunctionFeb 2, 2021Use of Device Problem; Use of Device Problem

  DURING THE PATIENT CALL, THE AUTOPULSE PLATFORM (SN (B)(4)) STOPPED COMPRESSIONS UNEXPECTEDLY THREE TIMES WITH A BLANK LCD SCREEN. THE BATTERY USED DURING THE CALL WAS FULLY CHARGED AND CORRECTLY INSERTED. DURING THE INCIDENT, THE CREW MEMBER NOTICED THAT THE LIFEBAND'S BELT ON THE RIGHT SIDE WAS SLIGHTLY TWISTED AND, PER THE REPORTER, BE A POSSIBLE CAUSE FOR THE PLATFROM'S INTERRUPTION. THERE WERE NO USER ADVISORIES DISPLAYED ON THE PLATFORM DURING THE ENTIRE CALL AND THE PLATFORM WORKED WITHOUT ISSUES BETWEEN THE STOPS. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE, THEREFORE THE PATIENT'S STATUS IS UNKNOWN. PLEASE SEE THE FOLLOWING RELATED MFR REPORTS: MFR 3010617000-2021-00070 FOR AUTOPULSE PLATFORM.

  Patient problems: Insufficient Information

  MAUDE report 11264475 ↗
• MalfunctionDec 16, 2020Use of Device Problem; Use of Device Problem

  DURING SHIFT CHECK, THE LIFEBAND (LOT # 146210) WAS ABLE TO CLIP TO THE CUSTOMER'S AUTOPULSE PLATFORM; HOWEVER, THE PLATFORM DISPLAYED A USER ADVISORY (UA) 12 (LIFEBAND NOT PRESENT) ERROR MESSAGE. PER CUSTOMER, THE LIFEBAND WAS NOT LOOSE AND DID NOT FALL OUT. THE USER REMOVED AND RE-INSTALLED THE LIFEBAND MULTIPLE TIMES TO TROUBLESHOOT, BUT THE ISSUE PERSISTED. THE LIFEBAND WAS REPLACED, AND THE UA12 ERROR MESSAGE WAS CLEARED. AS PER THE CUSTOMER, THE AUTOPULSE PLATFORM WAS ABLE TO FUNCTION PROPERLY WITH OTHER LIFEBANDS. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11024331 ↗
• MalfunctionNov 4, 2020Use of Device Problem; Use of Device Problem

  DURING TRAINING, THE LIFEBAND (LOT # 97059) WAS UNABLE TO BE RETRACTED, AND THE AUTOPULSE PLATFORM (SN: (B)(4)) DISPLAYED AN UNKNOWN USER ADVISORY (UA) ERROR MESSAGE. THE CUSTOMER REPORTED THAT THE LIFEBAND WAS OBSERVED DAMAGED ON THE STITCHES NEAR THE BELT CLIP. IT WAS ALSO REPORTED THAT THE BLACK PLASTIC LATCH OF THE AUTOPULSE LIFEBAND WAS BROKEN. NO PATIENT INVOLVEMENT. AS PER THE CUSTOMER, A SIMILAR ISSUE WAS OBSERVED ON DIFFERENT USER TRAINING SESSIONS. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2020-01088 FOR THE AUTOPULSE PLATFORM (SN: (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10783117 ↗
• MalfunctionSep 3, 2020Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  THE AUTOPULSE PLATFORM (SN (B)(4)) HAS A PIECE OF A LIFEBAND CLIP STUCK IN THE ENCODER DRIVE SHAFT AND UNABLE TO INSTALL A NEW LIFEBAND. PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED, THEREFORE PATIENT USE IS UNKNOWN. MFR: 3010617000-2020-00858 REFERENCES AUTOPULSE PLATFORM USED IN THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10489421 ↗
• MalfunctionJul 3, 2020Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  DURING PATIENT USE, CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) DISPLAYED USER ADVISORY - "(UA) 07" (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ON THE SCREEN PANEL. THE CREW REPOSITION THE PATIENT ON MULTIPLE OCCASIONS AND REPLACED THE AUTOPULSE LI-ION BATTERY BUT WAS UNABLE TO CLEAR THE ADVISORY. CREW IMMEDIATELY PERFORMED MANUAL CPR. ALSO, THE BELT CLIP ON THE LIFEBAND (LOT #97059) WAS BROKEN DURING PATIENT USE. PATIENT DEATH WAS REPORTED. THE AUTOPULSE PLATFORM ASSOCIATED WITH THIS LIFEBAND IS SUBMITTED UNDER MFR 3010617000-2020-00640.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10228496 ↗
• MalfunctionMay 29, 2020Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  DURING PATIENT USE, THE ALIGNMENT TAB OF THE LIFEBAND (LOT # 92272) GOT BROKEN. THE CUSTOMER REPORTED THAT THE LIFEBAND WAS IN GOOD CONDITION BEFORE THE ALIGNMENT TAB BROKE. HOWEVER, THE SIDE OF THE LIFEBAND, WHICH WAS INSTALLED INTO THE AUTOPULSE PLATFORM, SHOWED EXCESSIVE WEAR. PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE; THEREFORE, PATIENT'S STATUS IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10101110 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 02/04/2020, RECEIVED THE CUSTOMER FEEDBACK ABOUT THE PLATFORM STOPPED COMPRESSIONS AFTER EVERY SHOCK WHEN THE PLATFORM WAS SYNCHRONIZED WITH AED DEVICE (X SERIES). THE COMPRESSIONS WERE RESUMED AFTER THE USER PRESSED THE START BUTTON. ON 02/13/2020, RECEIVED AN UPDATE FROM THE CUSTOMER; DURING THE CALL, THE AUTOPULSE PLATFORM WAS USED ON AN OBESE PATIENT. PER REPORTER, THE PLATFORM WAS USED WITH AED DEVICE (X SERIES). THE AUTOPULSE PLATFORM WAS NOT CONNECTED TO THE AED DEVICE. THE PLATFORM STOPPED COMPRESSIONS AFTER EVERY SHOCK. THE COMPRESSIONS WERE RESUMED AFTER THE USER PRESSED THE START BUTTON. THE RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS NOT ACHIEVED AND THE PATIENT WAS PRONOUNCED DEAD. PER FORENSIC DOCTOR, THE PATIENT WAS DIAGNOSED WITH MULTIPLE RIB FRACTURES, PUNCTURED LUNG DUE TO BROKEN RIBS, PUNCTURED DIAPHRAGM DUE TO BROKEN RIBS, TANGENTIAL SKIN IRRITATION ON THE SIDE OF THE TORSO. IN ADDITION, THE PATIENT HAD FAT EMBOLISM IN BOTH LUNG WINGS. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2020-00223 FOR AUTOPULSE PLATFORM.

  Patient problems: Abrasion; Bone Fracture(s); Injury

  MAUDE report 9806820 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112998. One submission often covers many models, so check the product and lot details in each record.

• Z-0118-2023 · Sep 22, 2022 · Open, Classified
  AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR