Ambu® SPUR® II Adult Resuscitator 521611000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05707480152032), received between Aug 21, 2024 and Aug 21, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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 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.

• MalfunctionAug 21, 2024Mechanical Jam; Mechanical Jam

  ACCORDING TO THE COMPLAINT INFORMATION, DURING THE EVENT OF ADMINISTER RESCUE BREATHS TO A PATIENT IN DESTRESS, THE SPUR II DID NOT DEPRESS PROPERLY. IT WAS CHECHED THAT THE AMBU MASK WAS PROPERLY PLACED MULTIPLE TIMES, AS WELL AS CHECKING THE CONNECTION TO THE OXYGEN FLOWMETER. THE SPUR II WAS THROWN AWAY AND ANOTHER SPUR II WAS OPENED WITH THE SAME ISSUE. PER CUSTOMER: THERE DID NOT APPEAR TO BE ANY DEFORMITIES TO EITHER BAG. EVERYTHING APPEARED TO BE AS IT SHOULD BE. WHEN PLACED ON THE PATIENT'S FACE WE CHECKED SEVERAL TIMES FOR A GOOD SEAL BETWEEN AMBU MASK AND THE PATIENT, A GOOD SEAL WAS MADE, HOWEVER WHEN WE SQUEEZED THE BAG, WE COULD NOT PUSH AIR AT ALL. WE COULDN'T HEAR ANY AIR, NOR COULD WE SEE CHEST RISE AND FALL, THIS HAPPENED WITH BOTH BAGS. TOO MUCH TIME WAS SPENT TRYING TO GET IT TO WORK AND THEREFORE THE ANESTHESIA TEAM ASKED THAT WE DISCONTINUE USE AND ORDER A DIFFERENT BRAND. THE PATIENT DID STABILIZE DESPITE THE MALFUNCTION OF THE AMBU BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023061 ↗
• MalfunctionAug 21, 2024Mechanical Jam; Mechanical Jam

  ACCORDING TO THE COMPLAINT INFORMATION, DURING THE EVENT OF ADMINISTER RESCUE BREATHS TO A PATIENT IN DISTRESS, THE SPUR II DID NOT DEPRESS PROPERLY. IT WAS CHECKED THAT THE AMBU MASK WAS PROPERLY PLACED MULTIPLE TIMES, AS WELL AS CHECKING THE CONNECTION TO THE OXYGEN FLOWMETER. THE SPUR II WAS THROWN AWAY AND ANOTHER SPUR II WAS OPENED WITH THE SAME ISSUE. PER CUSTOMER: THERE DID NOT APPEAR TO BE ANY DEFORMITIES TO EITHER BAG. EVERYTHING APPEARED TO BE AS IT SHOULD BE. WHEN PLACED ON THE PATIENT'S FACE WE CHECKED SEVERAL TIMES FOR A GOOD SEAL BETWEEN AMBU MASK AND THE PATIENT, A GOOD SEAL WAS MADE, HOWEVER WHEN WE SQUEEZED THE BAG, WE COULD NOT PUSH AIR AT ALL. WE COULDN'T HEAR ANY AIR, NOR COULD WE SEE CHEST RISE AND FALL, THIS HAPPENED WITH BOTH BAGS. TOO MUCH TIME WAS SPENT TRYING TO GET IT TO WORK AND THEREFORE THE ANESTHESIA TEAM ASKED THAT WE DISCONTINUE USE AND ORDER A DIFFERENT BRAND. THE PATIENT DID STABILIZE DESPITE THE MALFUNCTION OF THE AMBU BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020981 ↗