MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE

Model Number 5-0236-91

Device Problem Device Inoperable (1663)

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

Event Type  malfunction  

Manufacturer Narrative

The customer did not return the product.An inventory evaluation was performed and functional testing was performed on in-house product of the same part number, no abnormalities were found.

Event Description

The customer alleges that "the laryngoscope blades light flickers and goes out.This happens repeatedly." no other details were provided and no patient injury/harm reported.

Manufacturer Narrative

Affected product was returned, the returned product was evaluated, and the defect was confirmed.A nonconformance has been opened to further investigate this defect.

Event Description

The customer alleges that "the laryngoscope blades light flickers and goes out.This happens repeatedly." 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, pakistan
• MDR Report Key: 7269925
• MDR Text Key: 100121863
• Report Number: 1036445-2018-00003
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 5-0236-91
• Device Lot Number: QK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Was the Report Sent to FDA?: No
• Patient Sequence Number: 1