SPUR® Adult Resuscitator 520611048ERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05707480154050), received between Aug 14, 2025 and Aug 14, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 14, 2025Material Deformation; Material Deformation

  PER THE CUSTOMER: "TODAY DURING A FULL ARREST WITH T20, THEY HAD TO SEND A MEMBER OUT TO THE MEDIC UNIT TO GRAB A NEW AMBU BAG BECAUSE THE ONE THEY WERE USING COLLAPSED AND WILL NOT EXPAND. THE SECOND AMBU BAG WHICH THEY GRABBED FROM A MEDIC UNIT WORKED FLAWLESSLY." AMBU BAG WAS DEFLATED UPON OPENING, WOULD NOT SUFFICIENTLY FILL THE BAG. WHEN CINCINNATI FIRE ARRIVED ON THE SCENE, THE PATIENT WAS TOO FAR GONE ALREADY. A SECOND BAG WAS USED AND WORKED AS INDICATED. PATIENT EXPIRED. THE BAGS MALFUNCTION DID NOT CONTRIBUTE TO THE PATIENTS OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22808402 ↗
• MalfunctionAug 14, 2025Material Deformation; Material Deformation

  PER THE CUSTOMER: "TODAY DURING A FULL ARREST WITH T20, THEY HAD TO SEND A MEMBER OUT TO THE MEDIC UNIT TO GRAB A NEW AMBU BAG BECAUSE THE ONE THEY WERE USING COLLAPSED AND WILL NOT EXPAND. THE SECOND AMBU BAG WHICH THEY GRABBED FROM A MEDIC UNIT WORKED FLAWLESSLY." AMBU BAG WAS DEFLATED UPON OPENING, WOULD NOT SUFFICIENTLY FILL THE BAG. WHEN CINCINNATI FIRE ARRIVED ON THE SCENE, THE PATIENT WAS TOO FAR GONE ALREADY. THE BAG WAS NOT RESPONSIBLE FOR PATIENTS' DEATH. A SECOND BAG WAS USED AND WORKED AS INDICATED. PATIENT EXPIRED. THE BAG WAS NOT RESPONSIBLE FOR PATIENTS' DEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22802795 ↗