MAUDE Adverse Event Report: VYAIRE MEDICAL VITAL SIGNS¿ HEAD POSITIONER; FREESTANDING HEADREST

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	08/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the vital signs¿ head positioner experienced patient getting pressure sores on facial region after use.
Additional Manufacturer Narrative
Result of investigation: photos received for evaluation.Sample not available.During the investigation process, device history records were reviewed for any discrepancies that might have occurred during production to explain the issue reported, nothing was found.The product does not contain any animal derivatives, bpa, cellulose, dehp, heavy metals, conflict materials, mercury, silicone, or plasticisers of any kind.The product is made of low-density polyethylene.The label states the product is not made with natural rubber latex, and the product has instructions for use that clearly give directions to ensure the patient is periodically reassessed to determine any issues that may develop during use.Nothing was found during the investigation that would lead quality control to conclude any manufacturing errors resulted in the rash on the patients faces.All customer complaints are monitored through our internal corrective and preventive action system for reoccurring issues, and if further investigation or action is deemed necessary, steps will be taken accordingly.

• Brand Name: VITAL SIGNS¿ HEAD POSITIONER
• Common Device Name: FREESTANDING HEADREST
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; 602 parkway, global park; box 180-3006; la aurora, 146 ; CS 146
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12550791
• Report Number: 3013421741-2021-00011
• Device Sequence Number: 11015111
• Product Code: HBM
• UDI-Device Identifier: 00749756999007
• UDI-Public: (01)00749756999007(10)52318871
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 52318871
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 09/29/2021
• Supplement Report FDA Received Date: 12/14/2021
• 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