MAUDE Adverse Event Report: SUNMED LLC SUNMED LLC; GREENLINE F/O AMER MAC SZ 0

Model Number 5-5231-00

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2022

Event Type  malfunction  

Event Description

Would not stay lit during use.Infant had to be re-intubated with a different blade.

Manufacturer Narrative

The laryngoscope not staying lit caused the infant to be re-intubated.This delayed treatment and intubation of 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 laryngoscope not staying lit caused the infant to be re-intubated.This delayed treatment and intubation of the patient.Based on the reported information and the event originating in the us, the criteria for reporting an adverse event have been met.Complaint history for this product for the past 24 months reviewed.There are no similar complaints.Without returned product, lot# or pictures returned, complaint cannot be verified.Sampling plan is in place to catch defects.Part of receiving inspection (rir-0219) is a functional test "verify illumination of blade when attached to handle" the ifu states: check to see that both bulbs are lit and functioning correctly - ensure that spare blades and handles are always available in case of failure or emergency.Risk(ra-46): r6: reduced or no visualization - light source not functional - s=5 o=1 rpn=5.Rpn < 25 therefore risk is acceptable.

Event Description

Would not stay lit during use.Infant had to be re-intubated with a different blade.

• Brand Name: SUNMED LLC
• Type of Device: GREENLINE F/O AMER MAC SZ 0
• 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: 14161273
• MDR Text Key: 298954733
• Report Number: 1314417-2022-00015
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5-5231-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/20/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other