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

Model Number	IPN048401
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/31/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11347952
• Report Number: 8030121-2021-00005
• Device Sequence Number: 14312667
• Product Code: CCW
• UDI-Device Identifier: 14026704626325
• UDI-Public: 14026704626325
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2021

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
• Operator of Device: No Information
• Device Expiration Date: 01/15/2025
• Device Model Number: IPN048401
• Device Catalogue Number: 004651004
• Device Lot Number: 2002741
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2021
• Supplement Date Received by Manufacturer: 01/31/2021
• Initial Report FDA Received Date: 02/19/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention