LifeBand® Load-distributing Band 100 (REF 8700-0701-16)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00849111001601), received between Nov 7, 2020 and May 5, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2023Break; Material Integrity Problem; Break; Material Integrity Problem

  DURING PATIENT USE, ONE OF THE HINGED BELT GUARDS (SKIRTS) OF THE LIFEBAND (LOT # 168928) BROKE APART. THE CUSTOMER CONTINUED THE RESUSCITATION ATTEMPT WITH MANUAL CPR. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16881627 ↗
• MalfunctionOct 13, 2021Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  AN AUTOPULSE PLATFORM #1 (SN UNKNOWN) WAS DEPLOYED BY THE EMS TEAM #1 FOR RESUSCITATING A (B)(6) YEARS OLD MALE PATIENT ((B)(6) KG) IN CARDIAC ARREST CAUSED BY PERSISTENT VENTRICULAR FIBRILLATION. THERE WERE NO SIGNS OR SYMPTOMS OF TRAUMA OBSERVED. THE CARDIAC ARREST WAS WITNESSED. THE MANUAL CPR WAS PERFORMED BY THE BYSTANDER FOR AN UNKNOWN PERIOD. THE BASIC LIFE SUPPORT STARTED 5-8 MINUTES AFTER THE COLLAPSE AND ADVANCE LIFE SUPPORT WAS STARTED 10 MIN AFTER THE COLLAPSE. THE CUSTOMER REPORTED THAT THE NEW MATERIAL OF THE AUTOPULSE LIFEBAND (LOT # UNKNOWN) IS TOO SOFT, CAUSING THE LIFEBAND TO BE MORE LIKELY TWISTED AROUND ITSELF, ON THE AUTOPULSE EDGES, WHILE TRYING TO BE INSTALLED ON THE AUTOPULSE PLATFORM. THIS ISSUE CAUSES THE AUTOPULSE DRIVESHAFT TO GET STUCK UPON TURNING ON. THE AUTOPULSE PLATFORM FAILS TO SIZE THE PATIENT. THE CUSTOMER TRIED TO PULL UP THE LIFEBAND, HOWEVER, THE ISSUE PERSISTED. THE EMS TEAM #1 CONTINUED PERFORMING THE MANUAL CPR UNTIL THE ARRIVAL OF EMS TEAM #2. THE EMS TEAM #2 DEPLOYED THE AUTOPULSE PLATFORM #2 (SN UNKNOWN), HOWEVER, THE SAME ISSUE PERSISTED. THE EMS TEAM CONTINUE PERFORMING THE MANUAL CPR FOR 38 MINUTES UNTIL THE PATIENT WAS TRANSFERRED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12621031 ↗
• MalfunctionOct 13, 2021Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  AN AUTOPULSE PLATFORM #1 (SN UNKNOWN) WAS DEPLOYED BY THE EMS TEAM #1 FOR RESUSCITATING A (B)(6) YEARS OLD MALE PATIENT ((B)(6)KG) IN CARDIAC ARREST CAUSED BY PERSISTENT VENTRICULAR FIBRILLATION. THERE WERE NO SIGNS OR SYMPTOMS OF TRAUMA OBSERVED. THE CARDIAC ARREST WAS WITNESSED. THE MANUAL CPR WAS PERFORMED BY THE BYSTANDER FOR AN UNKNOWN PERIOD. THE BASIC LIFE SUPPORT STARTED 5-8 MINUTES AFTER THE COLLAPSE AND ADVANCE LIFE SUPPORT WAS STARTED 10 MIN AFTER THE COLLAPSE. THE CUSTOMER REPORTED THAT THE NEW MATERIAL OF THE AUTOPULSE LIFEBAND (LOT # UNKNOWN) IS TOO SOFT, CAUSING THE LIFEBAND TO BE MORE LIKELY TWISTED AROUND ITSELF, ON THE AUTOPULSE EDGES, WHILE TRYING TO BE INSTALLED ON THE AUTOPULSE PLATFORM. THIS ISSUE CAUSES THE AUTOPULSE DRIVESHAFT TO GET STUCK UPON TURNING ON. THE AUTOPULSE PLATFORM FAILS TO SIZE THE PATIENT. THE CUSTOMER TRIED TO PULL UP THE LIFEBAND, HOWEVER, THE ISSUE PERSISTED. THE EMS TEAM #1 CONTINUED PERFORMING THE MANUAL CPR UNTIL THE ARRIVAL OF EMS TEAM #2. THE EMS TEAM #2 DEPLOYED THE AUTOPULSE PLATFORM #2 (SN UNKNOWN), HOWEVER, THE SAME ISSUE PERSISTED. THE EMS TEAM CONTINUE PERFORMING THE MANUAL CPR FOR 38 MINUTES UNTIL THE PATIENT WAS TRANSFERRED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12621030 ↗
• MalfunctionOct 13, 2021Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  AN AUTOPULSE PLATFORM #1 (SN UNKNOWN) WAS DEPLOYED BY THE EMS TEAM #1 FOR RESUSCITATING A (B)(6) YEARS OLD MALE PATIENT ((B)(6)KG) IN CARDIAC ARREST CAUSED BY PERSISTENT VENTRICULAR FIBRILLATION. THERE WERE NO SIGNS OR SYMPTOMS OF TRAUMA OBSERVED. THE CARDIAC ARREST WAS WITNESSED. THE MANUAL CPR WAS PERFORMED BY THE BYSTANDER FOR AN UNKNOWN PERIOD. THE BASIC LIFE SUPPORT STARTED 5-8 MINUTES AFTER THE COLLAPSE AND ADVANCE LIFE SUPPORT WAS STARTED 10 MIN AFTER THE COLLAPSE. THE CUSTOMER REPORTED THAT THE NEW MATERIAL OF THE AUTOPULSE LIFEBAND (LOT # UNKNOWN) IS TOO SOFT, CAUSING THE LIFEBAND TO BE MORE LIKELY TWISTED AROUND ITSELF, ON THE AUTOPULSE EDGES, WHILE TRYING TO BE INSTALLED ON THE AUTOPULSE PLATFORM. THIS ISSUE CAUSES THE AUTOPULSE DRIVESHAFT TO GET STUCK UPON TURNING ON. THE AUTOPULSE PLATFORM FAILS TO SIZE THE PATIENT. THE CUSTOMER TRIED TO PULL UP THE LIFEBAND, HOWEVER, THE ISSUE PERSISTED. THE EMS TEAM #1 CONTINUED PERFORMING THE MANUAL CPR UNTIL THE ARRIVAL OF EMS TEAM #2. THE EMS TEAM #2 DEPLOYED THE AUTOPULSE PLATFORM #2 (SN UNKNOWN), HOWEVER, THE SAME ISSUE PERSISTED. THE EMS TEAM CONTINUE PERFORMING THE MANUAL CPR FOR 38 MINUTES UNTIL THE PATIENT WAS TRANSFERRED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12621025 ↗
• MalfunctionNov 7, 2020Use of Device Problem; Use of Device Problem

  AS REPORTED, THE CUSTOMER WAS UNABLE TO PROPERLY INSTALL THE LIFEBAND (LOT # UNKNOWN) TO THE AUTOPULSE PLATFORM (SN: (B)(4)). WHEN THE LIFEBAND WAS INSTALLED, IT WAS LOOSE AND THE CLIPS DID NOT STAY-IN-PLACE DURING PATIENT TRANSPORT. AS PER THE CUSTOMER, THE ISSUE WAS OBSERVED WITH THE AUTOPULSE PLATFORM DURING BOTH SHIFT CHECKS AND PATIENT USE, AND DIFFERENT LIFEBANDS WERE TESTED; HOWEVER, THE SAME ISSUE WAS OBSERVED. NO ERROR MESSAGES OR FAULT CODES OBSERVED ON THE PLATFORM. NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2020-01102 FOR THE AUTOPULSE PLATFORM (SN: (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10805935 ↗

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