MAUDE Adverse Event Report: SALTER LABS DE MEXICO DE S.A. DE C.V. INTUBRITE; LARYNGOSCOPE, RIGID

Model Number MANUFACTURE'S NUMBER 2016C

Device Problem Defective Device (2588)

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

Event Date 04/23/2021

Event Type  malfunction  

Event Description

Lights will not work or are too dim to be effective on pediatric laryngoscopes.Many packages have been opened and wasted due to this happening.This has occurred in both illinois and wisconsin (advocate-aurora healthcare).Luckily no harm to patients thus far.Fda safety report id # (b)(4).

• Brand Name: INTUBRITE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): SALTER LABS DE MEXICO DE S.A. DE C.V.
• MDR Report Key: 11737244
• MDR Text Key: 248165217
• Report Number: MW5101017
• Device Sequence Number: 1
• Product Code: CCW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 04/23/2021
• 2 Devices were Involved in the Event: 1 2

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: MANUFACTURE'S NUMBER 2016C
• Device Lot Number: 2020-03-04 ADPS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other