MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE

Model Number 5-0236-99

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be submitted.

Event Description

The customer alleges that " the laryngoscope is dim , no longer will light or flickers after processing." no other details were provided and no patient injury/harm reported.

Manufacturer Narrative

The customer did not return any product to be reviewed nor did they provide photographic evidence.The defect description provided by the customer could not be replicated during an inventory evaluation however the complaint description can be confirmed through trending.

Event Description

The customer alleges that " the laryngoscope is dim , no longer will light or flickers after processing." no other details were provided and no patient injury/harm reported.

• Brand Name: GREENLINE
• Type of Device: LARYNGOSCOPE
• Manufacturer (Section D): MEDICAL DEVICES; wazirabad road, ugoki.; sialkot punjab,
• MDR Report Key: 9505510
• MDR Text Key: 198508759
• Report Number: 1314417-2019-00063
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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: 5-0236-99
• Device Lot Number: SH
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/15/2020
• Patient Sequence Number: 1