MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH EQUIPLITE SU MTL BLADE MAC 4; LARYNGOSCOPE, RIGID

Model Number IPN048401

Device Problem Optical Problem (3001)

Patient Problem Cardiac Arrest (1762)

Event Date 01/31/2021

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "happened during the intervention of the urgency ambulance.Involved a female patient.During the intubation of the patient, after the blade passed the tongue, the light stopped or blinked which led to increase the difficulty of the intubation.After few tries, the staff had a stabilized ray of light in order to visualize the glottis of the patient and finish the intubation.The batteries were changed, they are not the cause of the issue.Delay in the treatment reported.Patient deceased.Patient was reported to be in a state of cardiac-respiratory arrest when ambulance arrived.

Manufacturer Narrative

(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.

Event Description

It was reported that: "happened during the intervention of the urgency ambulance.Involved a female patient.During the intubation of the patient, after the blade passed the tongue, the light stopped or blinked which led to increase the difficulty of the intubation.After few tries, the staff had a stabilized ray of light in order to visualize the glottis of the patient and finish the intubation.The batteries were changed, they are not the cause of the issue.Delay in the treatment reported.Patient deceased.Patient was reported to be in a state of cardiac-respiratory arrest when ambulance arrived.

• Brand Name: RUSCH EQUIPLITE SU MTL BLADE MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11347952
• MDR Text Key: 232525340
• Report Number: 8030121-2021-00005
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704626325
• UDI-Public: 14026704626325
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN048401
• Device Catalogue Number: 004651004
• Device Lot Number: 2002741
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Death; Life Threatening; Required Intervention