SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520211000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05707480032747), received between Dec 17, 2021 and Dec 17, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “No Flow” (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. 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.

• InjuryDec 17, 2021Therapeutic or Diagnostic Output Failure

  PER MAUDE REPORT: PATIENT WAS IN DIALYSIS RECEIVING HER FIRST INTERMITTENT HEMODIALYSIS RUN AND AN HOUR INTO HER RUN, WENT UNRESPONSIVE. PATIENT STARTED DESATURATING, CLOSE FACE MASK APPLIED AT "FLUSH" RATE. PATIENT STILL UNABLE TO MAINTAIN GOOD SATURATIONS. EMERGENCY AMBU BAG THAT WAS IN ROOM WAS ACCESSED AND HOOKED UP TO OXYGEN, APPLIED OVER MOUTH, HOWEVER THE PATIENT CONTINUED TO DESATURATE DESPITE ATTEMPTING MANUAL BREATHS AND BEING HOOKED UP TO THE OXYGEN THROUGH AMBU BAG TUBING. PATIENT PLACED BACK ONTO CLOSED FACE MASK AND RRT ARRIVED AT BEDSIDE. AMBU BAG WAS HOOKED UP TO ANOTHER OXYGEN TREE IN ANOTHER ROOM TO ASSESS QUALITY AND FUNCTION AND WAS FOUND TO BE MALFUNCTIONED, NOT ALLOWING ANY AIR THROUGH THE MASK.

  Patient problems: Loss of consciousness; Low Oxygen Saturation

  MAUDE report 13026289 ↗
• MalfunctionDec 17, 2021No Flow; No Flow

  PER MAUDE REPORT: PATIENT WAS IN DIALYSIS RECEIVING HER FIRST INTERMITTENT HEMODIALYSIS RUN AND AN HOUR INTO HER RUN, WENT UNRESPONSIVE. PATIENT STARTED DESATURATING, CLOSE FACE MASK APPLIED AT "FLUSH" RATE. PATIENT STILL UNABLE TO MAINTAIN GOOD SATURATIONS. EMERGENCY AMBU BAG THAT WAS IN ROOM WAS ACCESSED AND HOOKED UP TO OXYGEN, APPLIED OVER MOUTH, HOWEVER THE PATIENT CONTINUED TO DESATURATE DESPITE ATTEMPTING MANUAL BREATHS AND BEING HOOKED UP TO THE OXYGEN THROUGH AMBU BAG TUBING. PATIENT PLACED BACK ONTO CLOSED FACE MASK AND RRT ARRIVED AT BEDSIDE. AMBU BAG WAS HOOKED UP TO ANOTHER OXYGEN TREE IN ANOTHER ROOM TO ASSESS QUALITY AND FUNCTION AND WAS FOUND TO BE MALFUNCTIONED, NOT ALLOWING ANY AIR THROUGH THE MASK.

  Patient problems: Low Oxygen Saturation

  MAUDE report 13023756 ↗