MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH POLARIS FO BLADE MAC 4; LARYNGOSCOPE, RIGID

Model Number IPN915503

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that "during intubation, no light despite the fact that the device had been tested in the morning.Apparently, the light works in upright position (blade over handle) but no light when upside down (blade under handle).Clinical consequences: the patient died.He was in cardiac arrest when he was being intubated.Awaiting additional information from the account.

Event Description

It was reported that "during intubation, no light despite the fact that the device had been tested in the morning.Apparently, the light works in upright position (blade over handle) but no light when upside down (blade under handle).Clinical consequences: the patient died.He was in cardiac arrest when he was being intubated.

Manufacturer Narrative

Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH POLARIS FO BLADE MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18517806
• MDR Text Key: 332925399
• Report Number: 3011137372-2024-00016
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704629715
• UDI-Public: 14026704629715
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN915503
• Device Catalogue Number: 4150140
• Device Lot Number: AB2303010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Sex: Male