MAUDE Adverse Event Report: PENTAX OF AMERICA, INC. PENTAX PHONATORY AERODYNAMIC SYSTEM; ELECTROGLOTTOGRAPH

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Good morning, after reviewing the ifu on reprocessing the pentax pas system, i discovered that the ifu is asking to reprocess the device with dakin's solution.Dakin's ifu specifies that the answer is for wound care, not hard surfaces.I have had meetings with pentax to report this oversite or to help suggest other solutions we have to reprocess, and they are not receptive.I appreciate your help, (b)(6) please let me know if you would like me to email the ifu.Airflow head-to-mask coupler.

• Brand Name: PENTAX PHONATORY AERODYNAMIC SYSTEM
• Type of Device: ELECTROGLOTTOGRAPH
• Manufacturer (Section D): PENTAX OF AMERICA, INC.
• MDR Report Key: 16861510
• MDR Text Key: 314584862
• Report Number: MW5117219
• Device Sequence Number: 1
• Product Code: KLX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1