MAUDE Adverse Event Report: SUNMED, LLC SUNONE SYSTEM; LARYNGOSCOPE, RIGID

Model Number 5-5336-02

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2022

Event Type  malfunction  

Event Description

Laryngoscope blade broke during intubation.

• Brand Name: SUNONE SYSTEM
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): SUNMED, LLC; 2710 northridge drive nw; suite a; grand rapids MI 49544
• MDR Report Key: 15629330
• MDR Text Key: 301998723
• Report Number: 15629330
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2022,09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5-5336-02
• Device Catalogue Number: 5-5336-02
• Device Lot Number: 215
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2022
• Device Age: 1 YR
• Date Report to Manufacturer: 10/18/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male