MAUDE Adverse Event Report: SALTER LABS SALTER LABS; MILLER 0 AND 1 DISPOSABLE LED BLADE, PEDIATRIC DISPOSABLE HANDLE 3/BATTERY

Model Number 1030.C,1031.C,2016.C

Device Problem Mechanical Problem (1384)

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

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

Failure of the device would delay the intubation of the patient.

Event Description

Light went dim and then out while intubating.

Manufacturer Narrative

Failure of the device would delay the intubation of the patient.Complaint confirmed with returned product.Inventory inspection performed and all units passed inspection.Reviewed complaint history for the 24 months preceding the complaint reporting dates.There were 5 complaints about the parts in that timeframe.There is no trending issue.Most likely root cause of the defect is an unintentional interruption in the circuitry, possibly from a soldering defect in manufacturing.Supplier reporting cannot be completed as a lot number was not given so this could be 3 different suppliers.Sent resolution to the customer.

Event Description

Light went dim and then out while intubating.

• Brand Name: SALTER LABS
• Type of Device: MILLER 0 AND 1 DISPOSABLE LED BLADE, PEDIATRIC DISPOSABLE HANDLE 3/BATTERY
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 16838887
• MDR Text Key: 314442121
• Report Number: 3000219639-2023-00011
• 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: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1030.C,1031.C,2016.C
• Device Catalogue Number: 1030.C,1031.C,2016.C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other