MAUDE Adverse Event Report: SUNMED LLC SUNMED LLC; GREENLINE SUNBRITE LED PENLITE HANDLE

Model Number 5-0236-90

Device Problem Intermittent Loss of Power (4016)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/02/2023

Event Type  malfunction  

Manufacturer Narrative

The laryngoscope not staying lit caused the infant to be re-intubated.This delayed treatment and intubation of the patient.

Event Description

Penlights are flickering and sometimes going out when in use.

Event Description

Penlights are flickering and sometimes going out when in use.

Manufacturer Narrative

The laryngoscope not staying lit caused the infant to be re-intubated.This delayed treatment and intubation of the patient.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.

• Brand Name: SUNMED LLC
• Type of Device: GREENLINE SUNBRITE LED PENLITE HANDLE
• Manufacturer (Section D): SUNMED LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED LLC; 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: 16271896
• MDR Text Key: 308474289
• Report Number: 1314417-2023-00004
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5-0236-90
• Device Catalogue Number: 5-0236-90
• Device Lot Number: VA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 01/02/2023
• Supplement Dates FDA Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other