ZOLL MFC 1007-0196-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00847946016807), received between Apr 13, 2017 and Dec 12, 2019 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (2 reports).

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 16, 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.

• MalfunctionDec 12, 2019Unable to Obtain Readings; Unable to Obtain Readings

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WAS UNABLE TO OBTAIN AN ECG SIGNAL VIA MULTIFUNCTION CABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 9457575 ↗
• MalfunctionFeb 15, 2018Connection Problem; Connection Problem

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED MULT-FUNCTION CABLE WOULD NOT CONNECT TO THE DEVICE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7274965 ↗
• MalfunctionMay 30, 2017Device Operational Issue; Device Operational Issue

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED MULTI-FUNCTION CABLE WAS UNABLE TO CONNECT TO THE DEVICE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6597639 ↗
• MalfunctionMay 22, 2017Connection Problem; Connection Problem

  COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE ASSOCIATED MULTI-FUNCTION CABLE WAS UNABLE TO CONNECT TO THE DEVICE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6582189 ↗
• MalfunctionApr 13, 2017Device Operational Issue; Device Operational Issue

  COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEFIBRILLATOR'S ASSOCIATED MULTI-FUNCTION CABLE "WAS NOT WORKING". NO FURTHER INFORMATION WAS AVAILABLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 6489631 ↗