MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED

Model Number 350-012-000

Device Problem Component Incompatible (1108)

Patient Problem No Information (3190)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device's blade were not attaching firmly to the handles.It was stated that it had been sliding off during the intubation process, both when the blade was inserted and when it was removed from the mouth after intubation.There was no reported patient outcome.

• Manufacturer (Section D): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer (Section G): AIRCRAFT MEDICAL LIMITED; 7 cross way; dalgety bay,fi KY11 9JE; GB KY11 9JE
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 8557199
• MDR Text Key: 147322679
• Report Number: 3010244187-2019-00004
• 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: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/26/2019

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: Health Professional
• Device Model Number: 350-012-000
• Device Catalogue Number: 350-012-000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 04/26/2019
• 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 Age: 70 YR