MAUDE Adverse Event Report: VYAIRE MEDICAL INC. VITAL SIGNS¿ HEAD POSITIONER; SUPPORT, PATIENT POSITION

Model Number	PRONE HEAD POSITIONER WITH MIRROR
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abrasion (1689); Ulcer (2274)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: 81 other - at this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.On follow-up, the customer indicated that they do not have suspect samples available because, after use, all the devices were disposed of.Also, the customer confirmed that from (b)(6) 2023, about 40-45 pieces were used but was not able to indicate the lot numbers.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
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.

• Brand Name: VITAL SIGNS¿ HEAD POSITIONER
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 17844563
• Report Number: 3013421741-2023-00038
• Device Sequence Number: 4401440
• Product Code: CCX
• UDI-Device Identifier: 00749756999007
• UDI-Public: (01)00749756999007
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PRONE HEAD POSITIONER WITH MIRROR
• Device Catalogue Number: 8000HDP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown