MAUDE Adverse Event Report: SALTER LABS SALTER LABS; PEDIATRIC DISPOSABLE HANDLE 3/BATTERY

Model Number 2016.C

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

Light on laryngoscope handle/blade went out after insertion.

Manufacturer Narrative

The light going out during intubation would delay and cause the patient's therapy to be delayed.

Manufacturer Narrative

The light going out during intubation would delay and cause the patient's therapy to be delayed.The complaint of "light on laryngoscope handle/blade went out after insertion" regarding part 2016.C was not confirmed.The root cause was not determined but could possibly be a result of faulty electrical connectivity.A risk assessment was performed, and the ultimate risk was determined to be medium.Capa-00510 is currently open for this issue.There have been 9 other complaints regarding the same part and a similar issue within the 24 months preceding the reporting of this issue.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

Event Description

Light on laryngoscope handle/blade went out after insertion.

• Brand Name: SALTER LABS
• Type of Device: 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: 18946340
• MDR Text Key: 338358706
• Report Number: 3000219639-2024-00032
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00607411964428
• UDI-Public: 00607411964428
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2016.C
• Device Catalogue Number: 2016.C
• Device Lot Number: 2022-10-15-ADPS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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