Medline MDSPHY100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888277635005), received between Apr 9, 2021 and Sep 18, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Shock/Stimulation” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Failure to Deliver Shock/Stimulation; Material Integrity Problem

  Patient problems: Atrial Fibrillation

  MAUDE report 50820581 ↗
• MalfunctionSep 12, 2026Unable to Obtain Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50746773 ↗
• MalfunctionApr 28, 2026Material Separation

  CUSTOMER STATES "PAD THAT WAS USED (ONE IN BIO BAG WITH LITERALLY NO GEL AT ALL ON THE PAD) AS WELL AS A NEW ONE I GRABBED ON SITE WHICH SHOWS THE GEL PEELING OF AS A RESULT OF TAKING THE PAPER PADS OFF."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020642 ↗
• MalfunctionApr 10, 2026Insufficient Device Problem Information

  DEFIBRILLATOR PAD DID NOT WORK DURING A CODE. CUSTOMER CHANGED OUT THE MACHINES.

  Patient problems: Insufficient Information

  MAUDE report 24845152 ↗
• MalfunctionMar 5, 2026Failure to Deliver Shock/Stimulation

  ACCORDING TO THE FACILITY, THERE WAS NO GEL ON THE DEFIB PADS CAUSING INABILITY TO SHOCK PATIENT AND DELAYED THE RESUSCITATION PROCESS.

  Patient problems: Insufficient Information

  MAUDE report 24521196 ↗
• MalfunctionApr 9, 2021Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  AS PER INITIAL REPORTER WHEN USING PRODUCT MDSPHY100 , "THE CLINICIAN FOLLOWED THE INSTRUCTIONS WHEN OPERATING THE PRODUCT. THE FIRST SHOCK DID NOT DELIVER AND A WRENCH CODE WAS DISPLAYED. THE CLINICIAN UNHOOKED THE WIRES AND HOOKED THEM BACK AGAIN. AT THIS TIME, THE CHARGE WAS DELIVERED WITH NO ISSUES. " THERE WERE NO SAMPLES OF THE PRODUCT RETURNED FOR EVALUATION AND NO SERIOUS INJURY OR DEATH WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11641818 ↗