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

Model Number VITAL SIGNS¿ HEAD POSITIONER

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burn(s) (1757)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported that the product sample and photo is available for analysis.At this time, vyaire has not received the suspect device for evaluation.Any additional information received from the customer will be included in a follow-up report.

Event Description

The customer reported that the patient underwent surgery while using the vital signs¿ head positioner.After the long procedure, the patient was discovered to have burns and ulcers around the jaw.

Manufacturer Narrative

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.Specifications provided to deroyal were examined and found to be correct and current.There have been no changes to the production process or the raw materials used to convert the foam positioner.The instructions for us that are placed with the product state to confirm the head positioner is properly fitted to the patient's face, assessing for pressure points, and to periodically reassess patients' position in the product for pressure points.During our investigation, nothing was found that would indicate a manufacturing error or discrepancy that would result in the injuries reported.It seems evident that the pressure ulcer or similar injuries were caused by clinicians negligence as no evidence has come up to show malfunction of the head positioner device.

• Brand Name: VITAL SIGNS HEAD POSITIONER
• Type of Device: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9765619
• MDR Text Key: 192676564
• Report Number: 9613793-2020-00007
• Device Sequence Number: 1
• Product Code: CCX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VITAL SIGNS¿ HEAD POSITIONER
• Device Catalogue Number: 8000HDP
• Device Lot Number: 49797348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other