MAUDE Adverse Event Report: SALTER LABS SALTER LABS; DISPOSABLE PEDIATRIC HANDLE-FIBER OPTIC

Model Number 6016.C

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/15/2024

Event Type  malfunction  

Event Description

The lights were so dim they could not see down a patient throat.

Manufacturer Narrative

The light going out during intubation would cause a disruption in patient therapy.The clinician would need to find a handle and blade that work further delaying the intubation and patient therapy.

Manufacturer Narrative

The light going out during intubation would cause a disruption in patient therapy.The clinician would need to find a handle and blade that work further delaying the intubation and patient therapy.The complaint of "lights not coming on, multiple laryngoscope handles" regarding part 2016.C was confirmed.The root cause 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 8 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

The lights were so dim they could not see down a patient throat.

• Brand Name: SALTER LABS
• Type of Device: DISPOSABLE PEDIATRIC HANDLE-FIBER OPTIC
• 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: 19136204
• MDR Text Key: 341125079
• Report Number: 3000219639-2024-00037
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 00607411964459
• UDI-Public: 00607411964459
• 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: 04/18/2024

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: 6016.C
• Device Catalogue Number: 6016.C
• Device Lot Number: 2024-01-10-GSADPS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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