MAUDE Adverse Event Report: MEDICAL DEVICES EVALUMED; LARYNGOSCOPE

Model Number 3-01B8-54

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

The device returned illuminates however when a blade is engaged and pulled on simulating intubation, the light will turn off.The device exhibits excessive wear from day to day use and was produced in (b)(6) 2016.The light cartridge is a replaceable item.The device failure is believed to be a result of extensive customer use.

Event Description

The customer alleges that "light is turning off when you pull back on the handle while intubating." no other details were provided and no patient injury/harm reported.

• Brand Name: EVALUMED
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab,
• MDR Report Key: 9675791
• MDR Text Key: 180029121
• Report Number: 1314417-2020-00007
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/06/2020

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: No Information
• Device Model Number: 3-01B8-54
• Device Lot Number: QD
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2020
• Type of Device Usage: N
• Patient Sequence Number: 1