MAUDE Adverse Event Report: SUNMED SUNMED; GREENLINE SUNBRITE LED MEDIUM HANDLE

Model Number 5-0236-99

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

Lights flickering when using the equipment.

Manufacturer Narrative

The defect caused the patient to have a delay in the intubation procedure.There was no patient injury, this incident will be reported.Intubation was hindered which delays in establishing a protected airway.Which increases the risk to the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.

Manufacturer Narrative

The defect caused the patient to have a delay in the intubation procedure.There was no patient injury, this incident will be reported.Intubation was hindered which delays in establishing a protected airway.Which increases the risk to the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.This complaint could not be confirmed because product or pictures were not returned.When a sample from the same lot was tested, the device functioned as intended.The light failure could be re-created if the lamp was partially unscrewed and the handle was re-assembled.It is possible that the customer did not fully screw in the lamp post-cleaning or the lamp had fully burnt out and needed to be replaced.According to ra-46, r33 or reduced visualization due to incorrect battery placement, the risk severity is 5 = significant and does not need to be reviewed at carb.

Event Description

Lights flickering when using the equipment.

• Brand Name: SUNMED
• Type of Device: GREENLINE SUNBRITE LED MEDIUM HANDLE
• Manufacturer (Section D): SUNMED; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 13459668
• MDR Text Key: 287585953
• Report Number: 1314417-2022-00002
• 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
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 5-0236-99
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other