MAUDE Adverse Event Report: AIRCRAFT MEDICAL LIMITED MCGRATH; LARYNGOSCOPE, RIGID

Model Number 300-000-000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 04/29/2016

Event Type  Injury  

Manufacturer Narrative

Title: effect of the mcgrath mac1 video laryngoscope on hemodynamic response during tracheal intubation: a retrospective study source: doi: published: plos one | doi:10.1371/journal.Pone.0155566 may 12, 2016 1.If information is provided in the future, a supplemental report will be issued.

Event Description

According to a literature source of study performed, the device had caused hypertension after the use of the device.After the intubation, 34 out of 68 patients had increased systolic blood pressure by 20%.

• Brand Name: MCGRATH
• Type of Device: LARYNGOSCOPE, RIGID
• 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: 9179118
• MDR Text Key: 161998009
• Report Number: 3010244187-2019-00014
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 300-000-000
• Device Catalogue Number: 300-000-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/11/2019
• 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 Outcome(s): Required Intervention
• Patient Age: 61 YR