MAUDE Adverse Event Report: TELEFLEX INCORPORATED RUSCH; LARYNGOSCOPE, RIGID

Model Number MILL0

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/27/2021

Event Type  malfunction  

Event Description

Health care providers could not get intubation light source from teleflex rush polaris to work properly.

• Brand Name: RUSCH
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 12868385
• MDR Text Key: 281204577
• Report Number: 12868385
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MILL0
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2021
• Date Report to Manufacturer: 11/24/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1