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.

• Brand Name: VITAL SIGNS HEAD POSITIONER
• Type of Device: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; 602 parkway, global park; box 180-3006; la aurora, 146 ; CS 146
• Manufacturer Contact: mindy faber ; 26125 n. riverwoods blvd.; mettawa, il ; 7570116
• MDR Report Key: 9771461
• MDR Text Key: 189318264
• Report Number: 9613793-2020-00008
• Device Sequence Number: 1
• Product Code: CCX
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other