AutoPulse®Resuscitation System 100 (REF 8700-0730-21)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00849111000697), received between Mar 14, 2016 and Sep 4, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) ERROR MESSAGE SEVERAL TIMES DURING THE DEVICE TEST WITH THE MANIKIN. THE USER VERIFIED CORRECT POSITION OF THE MANIKIN AND IS SECURED WITH THE SHOULDER STRAP ON THE PLATFORM. PER REPORTER, THE USER ADVISORY (UA) 02 ERROR ALSO DISPLAYED DURING THE TEST WITH SEVERAL AUTOPULSE LI-ION BATTERIES. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10492871 ↗
• MalfunctionMar 14, 2016Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED TO ZOLL THAT DURING USE ON A PATIENT, THE LIFEBAND ON THE AUTOPULSE (S/N (B)(4)) TIGHTENED TO APPROXIMATELY 10CM, THEN STOPPED WORKING. THE CUSTOMER REPORTED THAT THE AUTOPULSE DISPLAYED 2 ALERT MESSAGES: CHECK PATIENT LOCATION AND CHECK LIFEBAND. NO INFORMATION REGARDING THE PATIENT OR THE OUTCOME WAS GIVEN BY THE CUSTOMER AT THE TIME OF THIS REPORT. THE DEVICE WAS SENT TO (B)(4) (DISTRIBUTOR) FOR TESTING, BUT WHILE USING A MANNEQUIN, THE REPORTED ERROR MESSAGES COULD NOT BE DUPLICATED. THE DEVICE IS REPORTED TO BE WORKING APPROPRIATELY DURING TESTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5499369 ↗

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