AutoPulse®Resuscitation System 100 (REF 8700-0730-02)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00849111000550), received between Jun 15, 2016 and Mar 12, 2022 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 12, 2022Use of Device Problem; Use of Device Problem

  THE AUTOPULSE PLATFORM (SN UNKNOWN) WAS USED TO RESUSCITATE A PATIENT IN CARDIAC ARREST. THE USER INSTALLED THE NEW LIFEBAND (LOT# UNKNOWN) TO USE WITH THE PLATFORM, HOWEVER, THE PLATFORM COULD NOT MAKE COMPRESSIONS. THE CREW REVERTED TO MANUAL CPR FOR THE REST OF THE CALL. NO CONSEQUENCES OR IMPACT TO THE PATIENT. UPON RETURNING TO THE EMS CENTER, THE CREW NOTICED THAT THE LIFEBAND BAND CLIP THAT SNAPS INTO THE AUTOPULSE PLATFORM WAS BROKEN. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2022-00249 FOR THE AUTOPULSE LIFEBAND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13749163 ↗
• MalfunctionApr 11, 2019Use of Device Problem; Visual Prompts will not Clear; Use of Device Problem; Visual Prompts will not Clear

  DURING PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(4)) STOPPED COMPRESSIONS AFTER AN UNKNOWN PERIOD OF TIME AND DISPLAYED UNKNOWN USER ADVISORY (UA) ERROR MESSAGE. THE USER WAS UNABLE TO CLEAR THE ERROR MESSAGE. THE PLATFORM WAS CHECKED BY (B)(4) TECHNICIAN. DURING TESTING AT (B)(4), THE AUTOPULSE PLATFORM STOPPED COMPRESSIONS AFTER PERFORMING COMPRESSIONS FOR ABOUT 8 MINUTES AND DISPLAYED UA45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. THE USER EXPERIENCED DIFFICULTY IN REMOVING THE LIFEBAND FROM THE PLATFORM AND THE SHAFT WAS VERY HEAVY TO ROTATE MANUALLY. AFTER RE-POSITIONING THE LIFEBAND TO THE HOME POSITION, THE PLATFORM WAS RESTARTED. NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8506336 ↗
• MalfunctionSep 7, 2018Visual Prompts will not Clear; Visual Prompts will not Clear

  AS REPORTED, DURING SHIFT CHECK, THE USER'S AUTOPULSE PLATFORM (B)(4) DISPLAYED USER ADVISORY - UA07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE. THE USER WAS UNABLE TO CLEAR THE ADVISORY. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7857550 ↗
• MalfunctionAug 29, 2016Device Stops Intermittently; Device Stops Intermittently

  THE BIOMED REPORTED THAT THE AUTOPULSE PLATFORM (S/N: (B)(4)) STOPPED COMPRESSION AFTER 5 CYCLES. NO ERROR CODES/MESSAGES WERE OBSERVED. NO FURTHER INFORMATION WAS PROVIDED AND IT IS NOT KNOWN IF THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5912741 ↗
• InjuryJun 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2016, A (B)(6) WOMAN, WAS BEING SEEN IN THE EMERGENCY ROOM FOR THORACIC PAIN. IT IS UNKNOWN IF MANUAL CPR WAS PERFORMED BY A BYSTANDER PRIOR TO THE RESCUE TEAM ARRIVING. MANUAL CPR WAS PERFORMED BY THE RESCUE TEAM. IT IS UNKNOWN HOW LONG MANUAL CPR WAS PERFORMED. IN THE EMERGENCY ROOM (ER), THE PATIENT WENT INTO CARDIAC ARREST FOR VF (VENTRICULAR FIBRILLATION) WITH ACUTE CORONARY SYNDROME. THE ER STAFF BEGAN RESUSCITATION ON THE PATIENT USING AN IOT (INDUCTIVE OUTPUT TUBE), MCE (MEDICAL CARE EVALUATOR) AND THE AUTOPULSE PLATFORM. IT WAS REPORTED THAT THE RESCUE TEAM WHO BROUGHT THE PATIENT INTO THE HOSPITAL, PERFORMED MANUAL CPR AND CPR WITH THE AUTOPULSE PLATFORM DURING THIS RESUSCITATION (LENGTH OF TIME IS UNKNOWN). THE PATIENT ACHIEVED ROSC (RETURN OF SPONTANEOUS CIRCULATION) ONCE. WHEN THE PATIENT WAS BEING TRANSPORTED TO THE CORONAROGRAPHY ROOM (TO PERFORM A CORONARY ANGIOGRAPHY), SHE HAD A SECOND CARDIAC ARREST. THE PATIENT WAS BEING TRANSFERRED FOR ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) FOR SET UP. THE PATIENT WAS BEING PREPPED IN THE RIGHT FEMORAL ARTERY FOR A CORONARY ANGIOGRAPHY, ANGIOPLASTY AND STENT ON IVA (INTRAOPERATIVE VASCULAR ANGI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5728051 ↗

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