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

Model Number	VITAL SIGNS¿ HEAD POSITIONER
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Result of investigation: during the investigation process, the device history record was reviewed for any discrepancies that might have occurred during production to explain the issue reported, nothing was found.Current inventory was evaluated for any manufacturing defects; no errors or discrepancies were found.Due to the lack of a defective sample and the limited information provided, the issue could not be confirmed, and a root cause was not determined.

• 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: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16591676
• Report Number: 3010838917-2023-00048
• Device Sequence Number: 5326576
• Product Code: CCX
• UDI-Device Identifier: 00749756999007
• UDI-Public: (01)00749756999007(10)57973735
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VITAL SIGNS¿ HEAD POSITIONER
• Device Catalogue Number: 8000HDP
• Device Lot Number: 57973735
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 07/19/2023
• 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
• Patient Sex: Unknown