MAUDE Adverse Event Report: FLEXICARE MEDICAL LTD BRITEPRO SOLO; LARYNGOSCOPE

Catalog Number 040-334

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2023

Event Type  Death  

Event Description

Event occured as described below by complainant - "acute heart arrest/resucitation - bo light in the laryngoscope.Found another one from the same lot that worked." clinicians additonal comments as below - "patient died/was dead, resucitation failed.Clinician could not state that the defect laryngoscope cause the failure of resucitation.There was a small delay in intubation.".

Manufacturer Narrative

While "death" has been reported.This was not attributed to the laryngoscope device error - see below for clinicians comments: "patient died/was dead, resuscitation failed.Clinician could not state that the defect laryngoscope cause the failure of resuscitation.There was a small delay in intubation.".

• Brand Name: BRITEPRO SOLO
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): FLEXICARE MEDICAL LTD; cwm cynon business park; mountain ash, rct CF45 4ER; UK CF45 4ER
• Manufacturer (Section G): FLEXICARE MEDICAL LTD (CHINA); no.b-15; xicheng industrial zone; dongguan, guangdong 52346 5; CH 523465
• Manufacturer Contact: alex mcdonough ; cwm cynon business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 16973973
• MDR Text Key: 315665917
• Report Number: 3006061749-2023-00014
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 040-334
• Device Lot Number: 190800671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2019
• 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