MAUDE Adverse Event Report: VYAIRE MEDICAL DISPOSA-VIEW POSITIONER; SUPPORT, PATIENT POSITION

Model Number	HEAD POSITIONER
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer reported that the product 8000hdp had broken in half when the anesthetist moved patient (in prone position) 10cm down the bed while holding head in prone position-er.For intervention, product taped back together with sleek while patient prone to avoid delay.There was no delay in treatment.There was no patient harm reported.

• Brand Name: DISPOSA-VIEW 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.; box 180-3006, 602 parkway; box 180-3006; 146 ; CS 146
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 14721690
• Report Number: 3013421741-2022-00013
• Device Sequence Number: 14672008
• Product Code: CCX
• UDI-Device Identifier: 00749756999007
• UDI-Public: (01)00749756999007(10)55722094
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/25/2022

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: HEAD POSITIONER
• Device Catalogue Number: 8000HDP
• Device Lot Number: 55722094
• 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: 05/25/2022
• Initial Report FDA Received Date: 06/16/2022
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male