LifeBand® Load-distributing Band 100 (REF 8700-0701-03)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00849111065016), received between Oct 22, 2015 and Feb 9, 2022 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2022Break; Material Integrity Problem; Break; Material Integrity Problem

  DURING SHIFT CHECK, THE CUSTOMER INSTALLED LIFEBAND#1 (LOT #161862) TO TEST THE AUTOPULSE PLATFORM (SN (B)(4)). AFTER PERFORMING A FEW COMPRESSIONS, THE AUTOPULSE PLATFORM STOPPED WORKING WITH AN UNUSUAL SOUND AND DISPLAYED AN UNKNOWN ERROR MESSAGE. THE CUSTOMER OBSERVED THAT THE FABRIC HOLDING THE LIFEBAND BAND CLIP WAS TORN, AND THE BAND CLIP WAS DETACHED. THE CUSTOMER REPLACED IT WITH ANOTHER LIFEBAND #2 (LOT #161862) AND RESTARTED THE PLATFORM. SHORTLY AFTER COMPRESSION, THE HINGED BELT GUARD ON LIFEBAND GOT BROKEN WITH AN UNUSUAL SOUND. AFTER THE REPORTED ISSUE, THE CUSTOMER TESTED THE AUTOPULSE PLATFORM WITH ANOTHER LIFEBAND, AND THE PLATFORM FUNCTIONED AS INTENDED. NO PATIENT INVOLVEMENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-00104 FOR THE AUTOPULSE PLATFORM (SN (B)(4)). MFR 3010617000-2022-00105 FOR THE LIFEBAND #1 (LOT #161862).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502665 ↗
• MalfunctionFeb 9, 2022Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  DURING SHIFT CHECK, THE CUSTOMER INSTALLED LIFEBAND#1 (LOT #161862) TO TEST THE AUTOPULSE PLATFORM (SN (B)(4)). AFTER PERFORMING A FEW COMPRESSIONS, THE AUTOPULSE PLATFORM STOPPED WORKING WITH AN UNUSUAL SOUND AND DISPLAYED AN UNKNOWN ERROR MESSAGE. THE CUSTOMER OBSERVED THAT THE FABRIC HOLDING THE LIFEBAND BAND CLIP WAS TORN, AND THE BAND CLIP WAS DETACHED. THE CUSTOMER REPLACED IT WITH ANOTHER LIFEBAND #2 (LOT #161862) AND RESTARTED THE PLATFORM. SHORTLY AFTER COMPRESSION, THE HINGED BELT GUARD ON LIFEBAND GOT BROKEN WITH AN UNUSUAL SOUND. AFTER THE REPORTED ISSUE, THE CUSTOMER TESTED THE AUTOPULSE PLATFORM WITH ANOTHER LIFEBAND, AND THE PLATFORM FUNCTIONED AS INTENDED. NO PATIENT INVOLVEMENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-00104 FOR THE AUTOPULSE PLATFORM (SN (B)(4)) MFR 3010617000-2022-00106 FOR THE LIFEBAND #2 (LOT #161862)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13502664 ↗
• MalfunctionOct 23, 2021Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  DURING PATIENT USE, THE AUTOPULSE PLATFORM STOPPED COMPRESSION DUE TO THE DAMAGED HINGED BELT GUARD ON LIFEBAND #1 (LOT# 161862). THE CUSTOMER REPLACED THE LIFEBAND, HOWEVER, AFTER 5 MINUTES OF USE, THE ALIGNMENT TAB ON THE LIFEBAND #2 (LOT# 161862) GOT BROKEN DURING THE COMPRESSION. THE OBSERVED ALIGNMENT TAB ISSUE DID NOT AFFECT THE FUNCTION OF THE PLATFORM AND THE PLATFORM CONTINUED THE COMPRESSIONS WITHOUT STOPPING. NO CONSEQUENCES OR IMPACT TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686578 ↗
• MalfunctionJan 10, 2019Connection Problem; Connection Problem

  AS REPORTED, DURING SHIFT CHECK, THE LIFEBAND WAS UNABLE TO BE INSTALLED TO THE AUTOPULSE PLATFORM ((B)(4)). NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8236451 ↗
• MalfunctionJan 23, 2018Connection Problem; Connection Problem

  DURING PATIENT USE, THE CUSTOMER PRESSED THE START BUTTON ON AUTOPULSE PLATFORM (B)(4).; HOWEVER, THE UNIT FROZE AND WAS DISPLAYING AN ERROR MESSAGE "ANALYZING PATIENT SIZE". THE PLATFORM ALSO DID NOT ADJUST THE LIFEBAND. THE CREW THEN REVERTED TO MANUAL CPR. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS IS REPORT FOR LIFEBAND . FOR AUTOPULSE PLATFORM (B)(4) ISSUE SEE MFR 3010617000-2018-00118.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7214336 ↗
• MalfunctionMar 24, 2017Device Issue; Device Issue

  DURING A SHIFT CHECK, IT WAS OBSERVED THAT THE LIFEBAND ALIGNMENT TAB ON THE NEW LIFEBAND (LOT# 63423) WAS DETACHED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6432447 ↗
• MalfunctionAug 17, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE LIFEBAND (S/N: (B)(4)) WAS PLACED ON A PATIENT WHO SUFFERED A CARDIO-PULMONARY ARREST. ACCORDING TO THE CUSTOMER, NO SOONER WAS THE AUTOPULSE POWERED ON A "POP" WAS HEARD AND THE LIFEBAND SNAPPED. THE USE OF THE AUTOPULSE PLATFORM WAS DISCONTINUED AND ANOTHER CHEST COMPRESSIONS SYSTEM (LUCAS) WAS STARTED AND CONTINUED. NO KNOWN PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5884739 ↗
• MalfunctionOct 22, 2015Positioning Failure

  IT WAS REPORTED DURING A DEVICE CHECK, THAT THE AUTOPULSE LIFEBAND WOULD NOT REMAIN IN PLACE AS A RESULT OF A LOOSE CONNECTION. THERE WAS NO REPORT OF ANY PATIENT INVOLVEMENT. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5168584 ↗

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