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Regard™ C100AC-PHYSIORecalls & reported problems

Resource Optimization & Innovation, L.L.C. · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20326053106013), received between Apr 24, 2020 and Apr 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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

Device problems

  • Detachment of Device or Device Component1
  • Loose or Intermittent Connection1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 24, 2020Loose or Intermittent Connection; Detachment of Device or Device Component

    THE ADHESIVE ON THIS PAD IS VERY LOOSE. WHEN THE TEAM IS DOING CHEST COMPRESSIONS ON THE CODING PATIENT, THE PADS POP OFF. THE TEAM HAD TO STOP COMPRESSIONS AND RE STICK THE PAD ONTO THE PATIENT TO ANALYZE THE RHYTHM. WE HAVE HAD 3 INSTANCES SO FAR, WHERE THE NEW DEFIBRILATOR PADS COME OFF THE PATIENT'S CHEST WHILE WE ARE DOING CHEST COMPRESSIONS. (B)(4).

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9996209 ↗

Other Electrode, Electrodcardiograph, Multi-Function devices

All Electrode, Electrodcardiograph, Multi-Function devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.