LifeBand® Load-distributing Band 100 (REF 8700-0701-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 199 adverse event reports that list this exact device (DI 00849111001571), received between Sep 16, 2015 and Sep 30, 2026 — classified as 1 death, 4 injuries, 194 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (51 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 25 most recent of 199 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Integrity Problem; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952396 ↗
• MalfunctionDec 11, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  THE CUSTOMER REPORTED THAT UPON INSTALLING THE AUTOPULSE LIFEBAND (LOT # 206594), IT WAS DETERMINED THAT THE CLIP ON THE LIFEBAND WAS DAMAGED AND WOULDN'T BE INSTALLED CORRECTLY. CUSTOMER-PROVIDED PHOTOS SHOWED A BROKEN HINGED BELT GUARD. UPON RECEIPT AND INVESTIGATION AT ZOLL, THE LIFEBAND BAND CLIP (BELT CLIP) WAS MISSING, WHICH PREVENTED THE LIFEBAND FROM BEING INSTALLED ON THE AUTOPULSE PLATFORM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783935 ↗
• MalfunctionSep 11, 2025Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(6) SHUT OFF IN THE MIDDLE OF USE AFTER ABOUT 10 MINUTES. THE CUSTOMER STATED THAT THE CREW DID NOT REPORT ANY USER ADVISORY. THE CREW REPORTED THAT SOMETIMES LIFEBAND WOULD OPEN AT THE VELCRO. ACCORDING TO THE CUSTOMER, THE FEMALE PATIENT WEIGHED CLOSE TO 250 LBS., AND THE LIFEBAND FIT AROUND THE PATIENT'S CHEST PROPERLY. MANUAL CPR WAS INITIATED AND CONTINUED AFTER THE LIFEBAND OPENED. THE CREW DECIDED TO CONTINUE MANUAL CPR AND USE THE PLATFORM AS A HARD SURFACE TO TRANSPORT THE PATIENT ON. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23033096 ↗
• MalfunctionApr 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PATIENT # 2: DURING THE RESUSCITATION ATTEMPT USING THE AUTOPULSE PLATFORM (SN (B)(6), THE LIFEBAND (LOT #198870) TORE APART WHILE IN USE. THE CREW PERFORMED MANUAL CPR FOR THE REST OF THE CALL. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931328 ↗
• MalfunctionApr 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  PATIENT #1: DURING THE RESUSCITATION ATTEMPT ON A VSA (VASOSPASTIC ANGINA) CALL USING THE AUTOPULSE PLATFORM (SN (B)(6), THE LIFEBAND (LOT #UNKNOWN) TORE APART WHILE IN USE. THE CREW PERFORMED MANUAL CPR FOR THE REST OF THE CALL. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21931327 ↗
• MalfunctionFeb 19, 2025Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent

  THE AUTOPULSE PLATFORM (SN (B)(6)) ALONG WITH LIFEBAND (LOT # UNKNOWN) WERE USED IN AN ATTEMPT TO RESUSCITATE A PATIENT IN CARDIAC ARREST. THE CUSTOMER REPORTED THAT THE PATIENT WAS PROPERLY ALIGNED, AND CLOTHING WAS REMOVED, BUT THE LIFEBAND REPEATEDLY TWISTED. THE CUSTOMER STATED NO ERROR CODES WERE RECORDED, BUT THE CREW SWITCHED TO MANUAL CPR. THE CUSTOMER DID NOT PROVIDE FURTHER DETAILS ABOUT THE CARDIAC ARREST EVENT BUT REPORTED THAT THE PATIENT PASSED AWAY. THE CUSTOMER BELIEVES THE ISSUE WAS NOT DUE TO USER ERROR AND INDICATED THAT THE PATIENT'S DEATH WAS UNRELATED TO THE AUTOPULSE SYSTEM. THE CUSTOMER MENTIONED THAT THE REPORTED ISSUE WAS REPLICATED AT THE STATION AFTER THE CALL BUT DID NOT SPECIFY WHETHER IT WAS RELATED TO THE AUTOPULSE PLATFORM OR THE LIFEBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417564 ↗
• MalfunctionJan 29, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  THE AUTOPULSE PLATFORM (SN: (B)(6) WAS USED FOR RESUSCITATING A PATIENT. THE AUTOPULSE PLATFORM PERFORMED APPROXIMATELY 20 TO 30 MINUTES OF COMPRESSIONS BEFORE THE REPORTED ISSUE. AFTER RESUSCITATION AND UPON REMOVING THE LIFEBAND FROM THE AUTOPULSE PLATFORM BY THE HOSPITAL STAFF, THE LIFEBAND BAND CLIP BROKE. THE CUSTOMER COULD NOT REMOVE THE BROKEN CLIP FROM THE DRIVESHAFT, MAKING IT IMPOSSIBLE TO CONNECT A NEW LIFEBAND. NO CONSEQUENCES OR IMPACTS ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21266604 ↗
• MalfunctionJan 3, 2025Fitting Problem; Fitting Problem

  THE CUSTOMER REPORTED THAT WHILE ATTEMPTING TO USE THE AUTOPULSE PLATFORM (SN (B)(6) ON A FEMALE PATIENT SUFFERING A STEMI, THE AUTOPULSE LIFEBAND (LOT UNKNOWN) WOULD NOT CLIP IN CORRECTLY AND THEREFORE THE DEVICE DID NOT DELIVER COMPRESSIONS. THE CUSTOMER BELIEVED THIS WAS DUE TO A PLATFORM ISSUE. THERE WAS A RED WARNING LIGHT DISPLAYED BUT NO ERROR CODE. THE DISPLAYED MESSAGE WAS SHOWING "PULL UP LIFE BAND, CHECK PATIENT ALIGNMENT AND PRESS RESTART". TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE LIFEBAND WAS REPOSITIONED, AND THE DEVICE WAS RESTARTED BUT ONLY PERFORMED ONE COMPRESSION BEFORE STOPPING AGAIN. THE LIFEBAND WAS PULLED UP AND REALIGNED MULTIPLE TIMES, BUT THE ERROR CONTINUED, AND THE DEVICE WOULD NOT START. THE CUSTOMER REMOVED THE AUTOPULSE PLATFORM AND PERFORMED MANUAL COMPRESSIONS. MANUAL CPR WAS PERFORMED FOR 30 MINUTES. ROSC (RETURN OF SPONTANEOUS CIRCULATION) WAS NEVER ACHIEVED IN THIS CASE. THE CUSTOMER HAS CONFIRMED THE PATIENT DIED HOWEVER THE PATIENT OUTCOME IS NOT BELIEVED TO HAVE BEEN AS A RESULT OF DEVICE FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21074445 ↗
• MalfunctionJan 2, 2025Retraction Problem; Retraction Problem

  THE CUSTOMER REPORTED THE AUTOPULSE LIFEBAND (LOT UNKNOWN) WAS NOT RETRACTING OR COMPRESSING THE PATIENT. THE CREW DISCONTINUED USE OF THE AUTOPULSE PLATFORM (SN 32561) AND REVERTED TO MANUAL CPR. NO ADDITIONAL INFORMATION WAS PROVIDED. PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21063502 ↗
• MalfunctionNov 26, 2024Retraction Problem; Retraction Problem

  UPON BEING DISPATCHED TO A CARDIAC ARREST AT A RESIDENCE, THE CUSTOMER DEPLOYED THE AUTOPULSE PLATFORM (SN 37682) TO PROVIDE AUTOMATED CPR TO THE PATIENT. AFTER DELIVERING FIVE COMPRESSIONS, THE AUTOPULSE STOPPED, DISPLAYING A MESSAGE OF "REALIGN PATIENT" AND "PULL UP LIFEBAND". THE CREW REALIGNED THE PATIENT, ENSURING THE YELLOW IDENTIFICATION MARKER WAS VISIBLE UNDER THE PATIENT'S ARMPIT, BUT THE AUTOPULSE WOULD NOT RESTART. DESPITE FOUR MORE ATTEMPTS TO ADJUST THE LIFEBAND AND INSPECT THE PATIENT'S POSITIONING, THE LIFEBAND FAILED TO RETRACT AND FUNCTION. CONSEQUENTLY, THE EMS CREW REVERTED TO MANUAL CPR. NO CONSEQUENCES OR IMPACTS ON THE PATIENT. AFTER THE CALL, THE CUSTOMER INSPECTED THE AUTOPULSE PLATFORM AND LIFEBAND, WHICH REVEALED NO VISIBLE DAMAGE OR ISSUES. THE CUSTOMER MENTIONED THAT THE ISSUE MIGHT HAVE BEEN DUE TO USER ERROR OR A PROBLEM WITH THE LIFEBAND, BUT IT'S DIFFICULT TO DETERMINE SINCE THE LIFEBAND USED AT THE TIME WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783827 ↗
• MalfunctionSep 16, 2024Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  PATIENT #1 THE CUSTOMER REPORTED THAT DURING A PATIENT CALL, THE AUTOPULSE PLATFORM (SN (B)(6)) CAUSED ONE OF THE BANDS ON THE LIFEBAND TO TEAR, AND THE PLATFORM DISPLAYED AN UNKNOWN ERROR CODE WITH THE MESSAGE: "REPLACE LIFEBAND AND PRESS RESTART." THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 20228015 ↗
• MalfunctionSep 11, 2024Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  PATIENT #2: THE CUSTOMER REPORTED THAT DURING A PATIENT CALL, THE AUTOPULSE PLATFORM (SN (B)(6)) CAUSED ONE OF THE BANDS ON THE LIFEBAND TO TEAR, AND THE PLATFORM DISPLAYED AN UNKNOWN ERROR CODE WITH THE MESSAGE: "REPLACE LIFEBAND AND PRESS RESTART." THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 20196860 ↗
• MalfunctionAug 13, 2024Use of Device Problem; Use of Device Problem

  DURING A PATIENT CALL, THE AUTOPULSE LIFEBAND (LOT# UNKNOWN) DID NOT RETRACT TO SIZE THE PATIENT, AND HINGED BELT GUARDS FAILED TO SECURE IT TO THE AUTOPULSE PLATFORM (SN (B)(6). THE AREA ON THE BACK OF THE PLATFORM, WHERE THE LIFEBAND IS ATTACHED, WAS OBSERVED TO HAVE PHYSICAL DAMAGE AND THE LIFEBAND COULD NOT SNAP SECURELY TO THE AUTOPULSE PLATFORM. IN ADDITION, THE LIFEBAND TWISTED DURING THE SIZING OF THE PATIENT. THE PLATFORM WORKED FOR TWO MINUTES; HOWEVER, IT STOPPED WITHOUT DISPLAYING ANY ERROR MESSAGES. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978355 ↗
• MalfunctionJul 21, 2024Use of Device Problem; Use of Device Problem

  DURING THE PATIENT CALL, THE AUTOPULSE PLATFORM (SN (B)(6)) WAS UNABLE TO RETRACT THE LIFEBAND AND DISPLAYED A USER ADVISORY 34 (COMMUNICATION FAULT WITH POSITION ENCODER) ERROR MESSAGE. THE PLATFORM BATTERY WAS REINSTALLED AND THE DEVICE WAS POWERED ON NORMALLY. THE LIFEBAND (LOT# UNKNOWN) WAS PULLED UP AND PLACED ON THE PATIENT, HOWEVER, WHEN THE PLATFORM INITIATED THE RETRACTION, THE LIFEBAND SNAPPED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 19788294 ↗
• MalfunctionJul 17, 2024Use of Device Problem; Use of Device Problem

  DURING THE CALL, THE STAFF MEMBER WAS INFORMED THAT THE BELT GUARDS ON THE SIDE OF THE AUTOPULSE LIFEBAND (LOT# 181831) CAME UNLOCKED AND WOULD NOT CLICK BACK. THE CREW HAS DECIDED TO REMOVE THE DEVICE AND REPLACE IT WITH LUCAS TO PERFORM COMPRESSIONS. NO CONSEQUENCES OR IMPACT TO THE PATIENT. WHEN THE PLATFORM WAS REMOVED FROM THE PATIENT, THE BLACK COVER PLATE OF THE LIFEBAND CAME LOOSE, HOWEVER, THE LIFEBAND BELT CLIP WAS STILL IN THE SLOT OF THE DRIVE SHAFT. AFTER THE CALL, THE STAFF MEMBER CHANGED THE LIFEBAND AND DID NOT SEE ANY ERRORS ON THE DEVICE. THE DEVICE WAS TESTED OVER THE WEEKEND AND CONFIRMED TO BE FUNCTIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19768131 ↗
• MalfunctionApr 13, 2024Use of Device Problem; Use of Device Problem

  PER THE REPORTER, THE AUTOPULSE LIFEBAND (LOT # 182214) WAS DAMAGED. THE ISSUE WAS OBSERVED AFTER THE USE OF THE AUTOPULSE PLATFORM (SN (B)(6)) DURING THE PATIENT CALL. THE PATIENT'S STATUS INFORMATION WAS REQUESTED BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE. B3, THE DATE OF EVENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102786 ↗
• MalfunctionMar 29, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  DURING THE PATIENT CALL, THE CREW ATTEMPTED TO USE THE AUTOPULSE PLATFORM (SN UNKNOWN) ON A PATIENT BUT WERE UNABLE TO UTILIZE THE PLATFORM. THE CUSTOMER ASSUMES AN ERROR MESSAGE WAS DISPLAYED BUT IS UNSURE. THE CREW DID MANUAL CPR BEFORE AND AFTER THE ATTEMPT TO USE THE PLATFORM. THEY DID CPR FOR 25 MIN ON SITE AND ANOTHER 25 MIN IN THE HOSPITAL. NO IMPACT OR CONSEQUENCE TO THE PATIENT WAS REPORTED. AFTER THE CODE, THE PLATFORM WAS EXAMINED, AND THE CUSTOMER REPORTED THE PLASTIC CLIP OF THE AUTOPULSE LIFEBAND (LOT UNKNOWN) WAS DAMAGED INSIDE OF THE GEAR SHAFT OF THE AUTOPULSE PLATFORM. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2024-00261 FOR THE AUTOPULSE PLATFORM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19006063 ↗
• MalfunctionMar 29, 2024Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (B)(6) DISPLAYED PERSISTENT USER ADVISORY (UA) 34 (COMMUNICATION FAULT WITH POSITION ENCODER) UPON POWERING ON. THE REPRESENTATIVE ATTEMPTED TO CHANGE THE LIFEBAND, BUT THE ERROR PERSISTED. IN ADDITION, THE REPRESENTATIVE ALSO INDICATED THAT WHEN THE LIFEBAND WAS LOCKED INTO PLACE, THE LATCHES WERE LOOSE AND NOT TIGHT. 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 19005263 ↗
• MalfunctionMar 22, 2024Connection Problem; Connection Problem

  UPON INSTALLATION DURING THE SHIFT CHECK, THE CUSTOMER REPORTED THAT THE LIFEBAND (LOT #UNKNOWN) WAS NOT STAYING SECURED TO THE AUTOPULSE PLATFORM SN (B)(6). THE LIFEBAND GETS DISCONNECTED UPON PULL-UP/RETRACTION. THE PLATFORM DID NOT SHOW ANY USER ADVISORY OR FAULT CODES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18963511 ↗
• MalfunctionFeb 13, 2024Break; Use of Device Problem; Break; Use of Device Problem

  THE CUSTOMER INITIALLY REPORTED THAT THE AUTOPULSE PLATFORM SN (B)(6) HAD BROKEN DURING PATIENT USE. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THE LIFEBAND (LOT #158508) HAD BROKEN DURING PATIENT USE, AND THE AUTOPULSE PLATFORM USED DURING THE EVENT FUNCTIONS AS INTENDED. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 18699773 ↗
• MalfunctionJan 30, 2024Retraction Problem; Retraction Problem

  THE CUSTOMER REPORTED THAT DURING A PATIENT EVENT INVOLVING A 72-YEAR-OLD, 81.5 KG MALE PATIENT, THE AUTOPULSE PLATFORM (SN (B)(6)) WOULD NOT PERFORM ANY COMPRESSIONS. NO ERROR MESSAGES WERE OBSERVED. THE AUTOPULSE LIFEBAND (LOT UNKNOWN) WOULD NOT RETRACT. MANUAL CPR WAS PERFORMED FOR 37 MINUTES BUT THE PATIENT DIED. THE PATIENT WAS PRONOUNCED BY THE CONSULTANT CARDIOLOGIST. THE CUSTOMER DID NOT PROVIDE INFORMATION REGARDING THE RELATIONSHIP BETWEEN THE DEATH AND THE ALLEGED MALFUNCTION. HOWEVER, THE MSA EVALUATED THE INCIDENT AND IT WAS DETERMINED THAT THE DEATH WAS NOT RELATED TO THE AUTOPULSE DEVICE. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2024-00070 FOR THE AUTOPULSE PLATFORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611272 ↗
• MalfunctionJan 15, 2024Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn

  THE CUSTOMER REPORTED DURING PATIENT USE, THERE SEEMED TO BE AN ISSUE WITH THE WHITE RETENTION DISC OF THE AUTOPULSE PLATFORM (SN (B)(6)), WHERE EITHER IT OR IN COMBINATION WITH THE DRIVE SHAFT, IT IS SHEERING OFF PART OF THE AUTOPULSE LIFEBAND (LOT UNKNOWN) PIN. WITH A NEW BAND, THE PLATFORM WILL PERFORM 2-3 COMPRESSIONS THEN SHOW USER ADVISORY (UA) 12 (LIFEBAND NOT PRESENT) ERROR MESSAGE. THE CREW DID MANUAL COMPRESSIONS WHILE TROUBLESHOOTING THE DEVICE. ONCE IT WAS OBVIOUS THAT THE DEVICE WAS NOT GOING TO WORK ANYMORE, THEY SWITCHED TO CONTINUOUS MANUAL COMPRESSIONS. COMPRESSIONS WERE NEVER PAUSED MORE THAN A FEW SECONDS DURING THE TROUBLESHOOTING PROCESS. THE PIN OF THE LIFEBAND COULD BE REMOVED FROM THE DRIVESHAFT WITHOUT DEPRESSING THE DISC. THE SECOND LIFEBAND PERFORMED AS INTENDED IN OTHER PLATFORMS. NO IMPACT OR CONSEQUENCE TO THE PATIENT. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2024-00032 FOR THE AUTOPULSE PLATFORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18511106 ↗
• MalfunctionJan 12, 2024Break; Material Integrity Problem; Break; Material Integrity Problem

  DURING PATIENT USE, THE LIFEBAND (LOT # 189280) BAND CLIP BROKE OFF, PREVENTING IT FROM BEING SECURED INTO THE DRIVESHAFT SLOT OF THE AUTOPULSE PLATFORM. THE CREW REVERTED TO MANUAL CPR FOR THE REST OF THE CALL. THE PATIENT'S STATUS INFORMATION WAS REQUESTED, BUT THE CUSTOMER DID NOT PROVIDE A RESPONSE.

  Patient problems: Insufficient Information

  MAUDE report 18509183 ↗
• MalfunctionJan 5, 2024Fitting Problem; Fitting Problem

  DURING THE DEVICE CHECK, THE CUSTOMER REPORTED THAT THE LIFEBANDS WITH LOT #181831 ARE UNSECURED AND CAN EASILY COME OFF FROM THE ZOLL AUTOPULSE PLATFORMS (SN UNKNOWN). NO PATIENT INVOLVEMENT. RELATED MFR REPORT: MFR 3010617000-2024-00025 FOR THE AUTOPULSE PLATFORM #1. MFR 3010617000-2024-00021 FOR THE AUTOPULSE PLATFORM #2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18454749 ↗
• MalfunctionDec 5, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT THE LOCKING TABS ON THE COVER PLATE OF THE LIFEBANDS WITH LOT #181831 DO NOT SNAP INTO THE AUTOPULSE PLATFORM'S SLOTS AND CAN FALL OUT EASILY WITH A GENTLE TUG (THE SAME FORCE WHEN REPOSITIONING THE DEVICE). THE CUSTOMER HAD TO SECURE THE LIFEBAND TO THE AUTOPULSE PLATFORM USING ADHESIVE TAPE. THE CUSTOMER NOTED THE REPORTED PROBLEM WHILE USING THE LIFEBANDS WITH THE ZOLL LOANER AUTOPULSE PLATFORMS (SN (B)(6) AND (B)(6)). NO PATIENT INVOLVEMENT. ZOLL PERSONNEL VISITED THE CUSTOMER SITE AND TESTED THE LIFEBANDS WITH LOT #181831 WITH THE ZOLL LOANER AUTOPULSE PLATFORMS (SN (B)(6) AND (B)(6)), AND THE REPORTED ISSUE PERSISTED. THE LOANER AUTOPULSE PLATFORMS WERE TESTED WITH OTHER LIFEBANDS, AND THE ISSUE PERSISTED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2024-00022 FOR THE AUTOPULSE PLATFORM (SN (B)(6)). MFR 3010617000-2024-00024 FOR THE AUTOPULSE PLATFORM (SN (B)(6)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271825 ↗

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