LifeBand® Load-distributing Band 100 (REF 8700-0706-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10849111001691), received between Oct 11, 2018 and Nov 20, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT ONE OF THE AUTOPULSE LIFEBANDS (LOT # UNKNOWN) FROM THE 3-PACK WILL NOT CLIP INTO THE AUTOPULSE PLATFORM. NO FURTHER INFORMATION WAS PROVIDED. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23610370 ↗
• MalfunctionApr 18, 2023Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT DURING THE STRENUOUS EFFORT TO POSITION THE PATIENT ON THE X-RAY TABLE, THE LIFEBAND (LOT # UNKNOWN) BROKE APART. THE CUSTOMER SENT PICTURES SHOWING THAT ONE OF THE HINGED GUARDS OF THE LIFEBAND COVER PLATE WAS BROKEN. THE TYVEK LINER WAS RIPPED, AND THE BAND WAS JAMMED AND TWISTED. WHILE INSTALLING THE SECOND LIFEBAND (LOT # UNKNOWN), THE BAND LOCKING CLIP BROKE. THE CUSTOMER CONTINUED THE RESUSCITATION ATTEMPT WITH MANUAL CPR. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2023-00397 FOR THE FIRST LIFEBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766092 ↗
• MalfunctionApr 18, 2023Break; Material Integrity Problem; Material Split, Cut or Torn; Break; Material Integrity Problem; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT DURING THE STRENUOUS EFFORT TO POSITION THE PATIENT ON THE X-RAY TABLE, THE LIFEBAND (LOT # UNKNOWN) BROKE APART. THE CUSTOMER SENT PICTURES SHOWING THAT ONE OF THE HINGED GUARDS OF THE LIFEBAND COVER PLATE WAS BROKEN. THE TYVEK LINER WAS RIPPED, AND THE BAND WAS JAMMED AND TWISTED. WHILE INSTALLING THE SECOND LIFEBAND (LOT # UNKNOWN), THE BAND LOCKING CLIP BROKE. THE CUSTOMER CONTINUED THE RESUSCITATION ATTEMPT WITH MANUAL CPR. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2023-00411 FOR THE SECOND LIFEBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766089 ↗
• MalfunctionJun 29, 2022Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE LIFEBAND (LOT #UNKNOWN) WILL NOT CLIP ON THE AUTOPULSE PLATFORM (SN (B)(4) AND CLAIMED TO HAVE BROKEN OFF THE LIFEBAND'S BELT CLIP WHEN TRYING TO INSTALL ON THE AUTOPULSE PLATFORM. IT IS UNKNOWN WHEN THE PROBLEM OCCURRED. HOWEVER, PATIENT USE INFORMATION WAS REQUESTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR (B)(4) FOR THE AUTOPULSE PLATFORM (SN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 14857294 ↗
• MalfunctionOct 21, 2021Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE AUTOPULSE LIFEBAND (LOT #158870) DOES NOT CLIP TO THE AUTOPULSE PLATFORM. OUT OF THE THREE LIFEBAND RECEIVED, TWO ARE FUNCTIONAL. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12670738 ↗
• MalfunctionAug 19, 2021Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  THE LIFEBAND (LOT # 158335) WAS USED TO RESUSCITATE A PATIENT IN CARDIAC ARREST. BEFORE INSTALLING THE LIFEBAND TO THE AUTOPULSE PLATFORM, THE USER CHECKED THE PROPER ALIGNMENT OF THE LIFEBAND, AND NO TWIST WAS OBSERVED. AFTER AUTOPULSE PLATFORM WAS POWERED ON, NO COMPRESSIONS WERE PERFORMED BECAUSE THE LIFEBAND GOT TWISTED. PER THE CUSTOMER, THE AUTOPULSE PLATFORM DID NOT DISPLAY ANY ERROR MESSAGES. THE USER RE-STARTED THE AUTOPULSE 3 OR 4 TIMES AND CONTINUED TO USE THE AUTOPULSE, BUT THE ISSUE PERSISTED. IN ADDITION, THE USER STATED THAT SOMETIMES THE LIFEBAND RAGGED. NO DEATH OR INJURY WAS REPORTED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12346371 ↗
• MalfunctionJun 12, 2021Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  DURING DEVICE CHECK, THE LIFEBAND (LOT # UNKNOWN) SHEARED AT THE PLACE WHERE THE LIFEBAND ENTERS THE PLATFORM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11988567 ↗
• MalfunctionDec 31, 2020Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  THE AUTOPULSE PLATFORM SYSTEM WAS USED TO RESUSCITATE A (B)(6) MALE PATIENT IN CARDIAC ARREST. THE CAUSE OF CARDIAC ARREST IS UNKNOWN, AND IT WAS WITNESSED BY THE PATIENT'S SPOUSE. THE PATIENT WAS IN CARDIAC ARREST FOR ABOUT 4 MINUTES BEFORE RECEIVING MANUAL CPR, WHICH WAS PERFORMED BY THE POLICE, AND SUBSEQUENTLY, BY THE FIRE DEPARTMENT FOR APPROXIMATELY 16 MINUTES PRIOR TO THE USE OF THE AUTOPULSE PLATFORM. AFTER THE AUTOMATED CPR WAS PERFORMED FOR ABOUT 29 MINUTES, EN ROUTE TO THE HOSPITAL, THE LIFEBAND (LOT # UNKNOWN) WAS TORN. AFTER THE TEARING OF THE LIFEBAND, THE EMS CREW STOPPED USING THE AUTOPULSE AND REVERTED TO MANUAL CPR, WHICH WAS PERFORMED FOR ABOUT 9 MINUTES. RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS NOT ACHIEVED, AND THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL. AS PER THE CUSTOMER, THE PATIENT'S DEATH WAS NOT RELATED TO THE AUTOPULSE SYSTEM. AFTER THE CALL, WHILE THE CUSTOMER WAS TRYING TO REMOVE THE LIFEBAND FROM THE PLATFORM, IT WAS NOTED THAT THE LIFEBAND WAS TORN AT THE PLATFORM'S DRIVESHAFT, NEXT TO THE LIFEBAND CLIP. WHEN ATTEMPTING TO REMOVE THE LIFEBAND CLIP, THE CLOTH PORTION OF THE LIFEBAND BECAME COMPLETELY DETACHED FROM ITS CLIP, AND THE LIFEBAND

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11101231 ↗
• MalfunctionDec 29, 2020Use of Device Problem; Use of Device Problem

  PER A REPORTER, THE LIFEBAND 3 PACK HAD AN UNKNOWN ISSUE DURING THE CALL. THE ISSUE WAS NOTED WITHIN A FEW MINUTES AFTER THE PLATFORM STARTED COMPRESSIONS. ANOTHER PLATFORM WAS UTILIZED, HOWEVER, A SIMILAR ISSUE OCCURRED TWO MORE TIMES. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE, THEREFORE THE PATIENT'S STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11086054 ↗
• MalfunctionAug 21, 2020Use of Device Problem; Use of Device Problem

  DURING USE ON A FEMALE PATIENT WHO WAS APPROXIMATELY (B)(6) LBS. WITH LARGE BREAST/CHEST AREA, CUSTOMER REPORTED THAT THE LIFEBAND FAILED AFTER 18 MINUTES ON THE AUTOPULSE PLATFORM. PER REPORTER, THE AUTOPULSE PLATFORM WAS USED ON A FLAT TILE FLOOR WITH NO COMPLICATIONS. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE, THEREFORE PATIENT'S STATUS IS UNKNOWN. THE REPORT FOR AUTOPULSE PLATFORM IS SUBMITTED UNDER MFR 3010617000-2020-00878.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10440222 ↗
• MalfunctionOct 11, 2018Use of Device Problem; Use of Device Problem

  AS REPORTED, AFTER THE PATIENT WAS RESUSCITATED BY THE AUTOPULSE, THE LIFEBAND'S YELLOW ALIGNMENT TAB BROKE OFF AND THE LIFEBAND IMMEDIATELY CAME OFF FROM THE AUTOPULSE PLATFORM. THE ISSUE OCCURRED UPON ARRIVAL AT THE HOSPITAL. NO PATIENT CONSEQUENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7958569 ↗

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