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

Model Number	VITAL SIGNS¿ HEAD POSITIONER
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).No photographic evidence was supplied and no sample was returned.The device used on the patient was discarded and therefore the reported defect could not be confirmed.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 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.

• Brand Name: VITAL SIGNS¿ HEAD POSITIONER
• Common Device Name: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine CA 92618
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global parkbox 180-3006; 602 pkwy; la aurora, 146 ; CS 146
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, CA 92618
• MDR Report Key: 14811907
• Report Number: 3013421741-2022-00015
• Device Sequence Number: 4653208
• Product Code: CCX
• UDI-Device Identifier: 00749756999007
• UDI-Public: (01)00749756999007(10)00048523724
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2019

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: VITAL SIGNS¿ HEAD POSITIONER
• Device Catalogue Number: 8000HDP
• Device Lot Number: 00048523724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 06/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown