DeRoyal 8000HDPRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00749756999007), received between Sep 24, 2021 and Sep 29, 2023 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THERE WERE SIGNS OF DECUBITUS ON THE FACE AFTER PRONE-POSITION SURGERY. ACCORDING TO THE NEUROSURGEONS, THE VITAL SIGNS¿ HEAD POSITIONER OFTEN CAUSES REDNESS ON THE MOST EXPOSED PARTS OF THE PATIENT'S FACE, WHICH THEN DEVELOPS INTO ABRASIONS AND PRESSURE INJURIES. THE REDNESS PRESSURE SORES WERE DISCOVERED AT THE END OF THE SURGICAL PROCEDURE, AFTER USE OF THE POSITIONER.

  Patient problems: Abrasion; Ulcer

  MAUDE report 17844563 ↗
• MalfunctionMar 22, 2023Fracture; Fracture

  IT WAS REPORTED TO VYAIRE MEDICAL THAT DURING A PROCEDURE, A CRACK WAS OBSERVED ON THE PRONE HEAD POSITIONER WITH MIRROR. THE DEVICE WAS ON THE PATIENT BUT NO HARM OCCURRED AND NO INTERVENTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591676 ↗
• InjuryJun 25, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8000 HDP VITAL SIGNS¿ HEAD POSITIONER CAUSED PRESSURE WOUND TO A PATIENT WHEN USED. THE BURNS WERE SEEN ON THE FOREHEAD NEAR THE EYEBROWS. THE CUSTOMER REPORTED IT IS A PRESSURE WOUND THAT CAUSED MULTIPLE BURN WOUNDS ON THE FACE WITH BREAKAGE OF THE SKIN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14811907 ↗
• InjuryJun 25, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8000 HDP VITAL SIGNS¿ HEAD POSITIONER CAUSED PRESSURE WOUND TO A PATIENT WHEN USED. THE BURNS WERE SEEN ON THE FOREHEAD NEAR THE EYEBROWS. THE CUSTOMER REPORTED IT IS A PRESSURE WOUND THAT CAUSED MULTIPLE BURN WOUNDS ON THE FACE WITH BREAKAGE OF THE SKIN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 14811887 ↗
• InjuryJun 16, 2022Break; Break

  THE CUSTOMER REPORTED THAT THE PRODUCT 8000HDP HAD BROKEN IN HALF WHEN THE ANESTHETIST MOVED PATIENT (IN PRONE POSITION) 10CM DOWN THE BED WHILE HOLDING HEAD IN PRONE POSITION-ER. FOR INTERVENTION, PRODUCT TAPED BACK TOGETHER WITH SLEEK WHILE PATIENT PRONE TO AVOID DELAY. THERE WAS NO DELAY IN TREATMENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14721690 ↗
• InjurySep 29, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS¿ HEAD POSITIONER EXPERIENCED PATIENT GETTING PRESSURE SORES ON FACIAL REGION AFTER USE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12550791 ↗
• InjurySep 29, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS¿ HEAD POSITIONER EXPERIENCED PATIENT GETTING PRESSURE SORES ON FACIAL REGION AFTER USE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12550717 ↗
• InjurySep 29, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT AFTER USING THE 8000HDP VITAL SIGNS¿ HEAD POSITIONER, THE PATIENT GETTING PRESSURE SORES ON FACIAL REGION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12550661 ↗
• InjurySep 29, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT AFTER USING THE 8000HDP VITAL SIGNS¿ HEAD POSITIONER, THE PATIENT GETTING PRESSURE SORES ON FACIAL REGION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12550623 ↗
• InjurySep 29, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT AFTER USING THE 8000HDP VITAL SIGNS¿ HEAD POSITIONER, THE PATIENT GETTING PRESSURE SORES ON FACIAL REGION.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 12550561 ↗
• MalfunctionSep 28, 2021Break; Break

  THE CUSTOMER REPORTED THAT THE VITAL SIGNS¿ HEAD POSITIONER EXPERIENCED FISSURE IN IT. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541470 ↗
• InjurySep 27, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8000HDP VITAL SIGNS¿ HEAD POSITIONER WAS HARDER THAN THE OTHER SUPPLY, CAUSING SKIN RASH ON PATIENTS' FACES.

  Patient problems: Rash

  MAUDE report 12537666 ↗
• InjurySep 27, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8000HDP VITAL SIGNS¿ HEAD POSITIONER WAS HARDER THAN THE OTHER SUPPLY, CAUSING SKIN RASH ON PATIENTS' FACES.

  Patient problems: Rash

  MAUDE report 12537206 ↗
• InjurySep 27, 2021Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8000HDP VITAL SIGNS¿ HEAD POSITIONER WAS HARDER THAN THE OTHER SUPPLY, CAUSING SKIN RASH ON PATIENTS' FACES.

  Patient problems: Rash

  MAUDE report 12535953 ↗
• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8000 HDP VITAL SIGNS¿ HEAD POSITIONER SPLIT INTO TWO WHILE ON PATIENT USE, HOWEVER, IT WAS CONFIRMED THAT THERE WAS NO HARM ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12530278 ↗
• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8000 HDP VITAL SIGNS¿ HEAD POSITIONER SPLIT INTO TWO WHILE ON PATIENT USE, HOWEVER, IT WAS CONFIRMED THAT THERE WAS NO HARM ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12529462 ↗