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

Model Number	VITAL SIGNS¿ HEAD POSITIONER
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Rash (2033)
Date of Event	08/30/2021
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.The issue occurred with 3 patients.Please refer to (b)(4) for the other 2 patients.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 8000hdp vital signs¿ head positioner was harder than the other supply, causing skin rash on patients' faces.
Additional Manufacturer Narrative
During the investigation process, the device history records were reviewed for any discrepancies that might have occurred, during production to explain the issue reported.Nothing was found.Current inventory was evaluated for any visible manufacturing defects; no errors, defects, or discrepancies were found.Deroyal is the contract manufacturer for the finished good involved in the reported event.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.

• Brand Name: VITAL SIGNS¿ HEAD POSITIONER
• Common Device Name: SUPPORT, PATIENT POSITION
• 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; 146 ; CS 146
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12537666
• Report Number: 3013421741-2021-00005
• Device Sequence Number: 13777154
• Product Code: CCX
• UDI-Device Identifier: 00749756999007
• UDI-Public: (01)00749756999007(10)53916784
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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): 08/30/2021

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: 53916784
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 09/27/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown