MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN BRITEPRO SOLO SINGLE USE FIBER OPTIC LARYNGOSCOPE HANDLE

Catalog Number 040-310U

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 12/16/2021

Event Type  malfunction  

Event Description

A patient began to code at approximately 7:40am.The clinician opened one 040-310u handle from the crash cart, connected it to a disposable blade of unknown vendor from the crash cart, and found that the handle would not work.The clinician then opened a second 040-310u handle of the same lot number and found that its light would not work.The clinician then attempted to secure an i-gel lma in the patient airway but could not gain a proper seal.The clinician attempted to secure a second i-gel lma in the patient's airway but again could not gain a seal.At some point earlier in this event, the clinician called for a c-mac video laryngoscope, however after the second failed lma attempt, it had not arrived yet.The clinician then began chest compressions for approximately tem minutes before the code was announced as complete at approximately 7:55am.

• Brand Name: BRITEPRO SOLO SINGLE USE FIBER OPTIC LARYNGOSCOPE HANDLE
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer (Section G): FLEXICAREMEDICAL DONGGUAN; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: julie davies ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 13059527
• MDR Text Key: 284684085
• Report Number: 3006061749-2021-00013
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/22/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 040-310U
• Device Lot Number: 180200161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2021
• Initial Date FDA Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2018
• 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
• Patient Outcome(s): Death