Abstract: Medtronic is recalling sure McGrath MAC video laryngoscopes and updating utilization directions for one more as a consequence of potential battery overheating, which may result in critical security dangers, together with burns, scarring, respiratory failure, and in excessive circumstances, demise. The recall, recognized by the FDA as probably the most critical kind, entails eradicating the affected units and offering up to date directions for next-generation fashions to stop battery instability. Medtronic has notified prospects and issued tips for correct machine disposal and dealing with.
Key Takeaways:
- Product Recall Because of Battery Dangers: Medtronic is recalling particular McGrath MAC video laryngoscopes as a result of the batteries in these units may overheat and doubtlessly explode, posing extreme security dangers to sufferers and customers.
- Medtronic Removes Sure Gadgets: Medtronic is eradicating McGrath MAC and MAC EMS video laryngoscopes as a consequence of battery instability dangers, instructing customers to eliminate the battery meeting and return the units.
- Up to date Directions for Subsequent-Era Gadgets: The subsequent-generation McGrath MAC video laryngoscopes usually are not being eliminated, however Medtronic has issued up to date battery dealing with directions to stop potential dangers, together with correct storage and disposal tips.
Medtronic is eradicating sure McGrath MAC video laryngoscopes and updating use directions for one more because of the risk that the battery might deplete under its designed threshold. If this occurs, it will increase the chance of battery instability and should result in elevated battery temperature and a possible explosion.
Using the affected product might trigger critical antagonistic well being penalties, together with burns, cuts, scarring and different tissue accidents, tooth loss, eye harm, broken listening to,or ringing within the ears, respiratory failure, lack of oxygen to the physique, scarring, and demise.
There was one reported harm. There have been no experiences of demise.
The US Meals and Drug Administration has recognized this recall as probably the most critical kind. This machine might trigger critical harm or demise should you proceed to make use of it.
Affected Product
McGrath MAC video laryngoscope with labels for 3.6v battery Use By Date and serial quantity.
For machine elimination:
- Product names: McGrath MAC Video Laryngoscope, McGrath MAC EMS video laryngoscope
- Distinctive machine identifier (UDI)/Mannequin: 15060272980020/300-000-000 and 15060272980129/300-200-000
- Serial numbers: All serial numbers between 366170 to 405673
To be used directions updates:
- Product title: Subsequent-generation McGrath MAC video laryngoscope
- Distinctive machine identifier (UDI)/Fashions: 10884521823396/301-000-000 and 10884521776494/301-000-000
What to Do
For McGrath MAC and MAC EMS video laryngoscopes, don’t use these units. Take away the battery meeting and throw it away in response to native tips.
For McGrath MAC video laryngoscope (subsequent era):
- Observe that these units usually are not being eliminated.
- Evaluate the up to date battery dealing with addendum to the Directions for Use earlier than utilizing the machine.
- This replace contains the next directions:
- Don’t use a battery previous the “Use by date” discovered on the McGrath 3.6V battery meeting (340-000-000).
- Observe correct battery storage circumstances discovered within the product directions to be used.
- Eliminate battery assemblies in response to native tips and substitute with a brand new McGrath 3.6V labeled battery meeting if:
- The battery meeting has not been saved within the circumstances outlined within the IFU.
- The battery meeting was dropped.
In July, Medtronic despatched all affected prospects an Pressing Medical Gadget Elimination and Correction letter recommending the next further actions:
For McGrath MAC and MAC EMS video laryngoscopes
- Return the units (300-000-000 and 300-200-000) to Medtronic after disposing of the battery meeting in response to native tips.
For McGrath MAC video laryngoscope (subsequent era)
- Proceed utilizing Subsequent-generation McGrath video laryngoscopes (301-000-000).
- Observe essential battery dealing with info within the directions to be used and supplied within the discover.
- Make a copy of the directions to be used addendum with the unique directions to be used.
For all units (no matter elimination or up to date directions to be used)
- Move this discover on to all who have to be conscious inside the group or to any group the place the affected product might have been transferred or distributed.
- Full a buyer affirmation kind even should you shouldn’t have affected stock.
Clients within the US with questions on this recall ought to contact their Medtronic consultant or customer support at 800-962-9888, possibility 2.