LifeBand® Load-distributing Band 100 (REF 8700-0706-14)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10849111002247), received between May 6, 2020 and Mar 13, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  DURING CHECKING LIFEBANDS BEFORE TREATMENT, THE CUSTOMER FOUND THE BAND CLIP AND HINGED BELT GUARD OF THE TWO NEWLY RECEIVED LIFEBANDS (LOT#190702) WERE BROKEN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896190 ↗
• MalfunctionMar 13, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  DURING CHECKING LIFEBANDS BEFORE TREATMENT, THE CUSTOMER FOUND THE BAND CLIP AND HINGED BELT GUARD OF THE TWO NEWLY RECEIVED LIFEBANDS (LOT#190702) WERE BROKEN. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896164 ↗
• MalfunctionOct 16, 2023Fitting Problem; Fitting Problem

  DURING SHIFT CHECK, ONE OF THE HINGED BELT GUARDS OF THE LIFEBAND (LOT 173316) HAD SOME ISSUES AND WAS UNABLE TO ENGAGE TO THE ROLLER. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17941177 ↗
• MalfunctionMay 8, 2020Use of Device Problem; Use of Device Problem

  DURING THE PATIENT USE, THE PLATFORM DISPLAYED USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) ERROR. THE LIFEBAND WAS NOTED TWISTED INTERMITTENTLY DURING THE OPERATION. THE USER REINSTALLED THE LIFEBAND TO MAKE SURE IT IS PROPERLY INSTALLED, HOWEVER, THE ISSUE PERSISTS. THE CREW IMMEDIATELY REVERTED TO MANUAL CPR. NO CONSEQUENCES OR IMPACT TO PATIENT. THE PLATFORM WAS TESTED BACK AT THE STATION AND WAS CONFIRMED TO PERFORM AS INTENDED WITH THE NEW LIFEBAND. PER A REPORTER, THE LIFEBAND WITH THE ISSUE WAS INSTALLED ON THE PLATFORM FOR ABOUT A MONTH. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2020-00484 FOR AUTOPULSE PLATFORM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10041026 ↗
• MalfunctionMay 7, 2020Material Twisted/Bent; Material Twisted/Bent

  DURING PATIENT USE, CUSTOMER REPORTED THAT LIFEBAND WAS TWISTED INTERMITTENTLY ON THE AUTOPULSE PLATFORM (SERIAL #(B)(4)) WHILE OPERATING AND IT DISPLAYED ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) ERROR MESSAGE. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE, THEREFORE PATIENT'S STATUS IS UNKNOWN. THE AUTOPULSE PLATFORM ASSOCIATED WITH THIS COMPLAINT IS SUBMITTED UNDER MFR 3010617000-2020-00487.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10037040 ↗
• MalfunctionMay 6, 2020Use of Device Problem; Use of Device Problem

  THE AUTOPULSE PLATFORM (SN: (B)(4)) WAS USED TO TREAT A PATIENT IN CARDIAC ARREST. THE PATIENT WAS PLACED ON THE PLATFORM, AND THE COMPRESSIONS WERE PERFORMED FOR ALMOST 30 MINUTES. THEN, THE PLATFORM STOPPED COMPRESSIONS AND DISPLAYED USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) ERROR MESSAGE. AS REPORTED, THE LIFEBAND (LOT # 143423) KEPT GETTING TWISTED INTERMITTENTLY, AND THE ISSUE WAS OBSERVED 2 OR 3 TIMES DURING THE USE OF THE PLATFORM. THE USER TRIED TO CLEAR THE ERROR MULTIPLE TIMES, BUT THE ISSUE WAS NOT RESOLVED. NO CONSEQUENCES OR IMPACT TO PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR # 3010617000-2020-00482 FOR THE AUTOPULSE PLATFORM (SN: (B)(4)).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10030438 ↗

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