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Battery-Powered Mobile Medical Cart Problems Cheat Sheet by

Tips for Battery Powered Medical Carts from FDA
medical     problems     fire     fda     carts

Introd­uction

The FDA regulates medical carts under section 201(h) of the Federal Food, Drug and Cosmetic Act. In some cases, the batter­y-p­owered cart itself has a therap­eutic function (e.g., medication dispensing carts). In other cases, the cart can function as an accessory to medical devices, such as colono­scopes, ultrasound machines, and anesthesia machines.

FDA has received medical device reports of hospital fires and other health hazards associated with batteries used in mobile medical carts and their chargers. These events, which range from smoke production and overhe­ating to equipment fires and explosion, can occur with lithium, lead acid, and other types of batteries. Such hazards may result in equipment and facility damage, hospital evacuation or patient and staff injury.

In addition, lithium battery fires are very difficult to exting­uish. In several reports, firefi­ghters had to bury mobile medical cart batteries to extinguish a fire.

FDA Recomm­end­ations Preventive Mainte­nance

Inspect batteries for signs of damage, including bulging, swelling, or cracks.
Notify the manufa­cturer of damaged batteries.
Inspect battery chargers and carts containing chargers for overhe­ating compon­ents.
Vacuum to remove dust and lint around battery chargers and carts containing chargers.
Do not use batteries that do not charge properly. Ensure that batteries are replaced at the manufa­cturer recomm­ended replac­ement intervals.
Conduct a survey of battery charger locations, and verify that all chargers are located in easily visible, fire retardant locations away from patient care areas and open sources of oxygen.
Do not install chargers or charging carts in confined spaces.
Keep flammable and explosive objects away from battery chargers and charging carts.
Request preven­tative mainte­nance docume­ntation from the cart manufa­cturer for the health care facility to use.

If a fire occurs

If a battery in a mobile medical cart catches fire:
Immediately report the fire according to your hospital protocol. Follow hospital protocol for addressing a Class C electrical fire disclaimer icon.
Do not touch the battery.
Unplug the charger or power off the cart if it is safe to do so.
Remove the cart from patient and visitor areas, as safely as possible.
 

FDA Warning

General Recomm­end­ations

Do not block any charging station vents.
Do not tape or attach any object or material to a battery charger.
Only operate and store the battery charger and cart with charger outside of patient rooms and in non-pa­tient care areas.
Contact the manufa­cturer if there is a problem with any component of this system. This alerts the manufa­cturer of a potential product concern.
Request mainte­nance and user manuals for the carts, chargers, batteries, and all access­ories.
Before purchasing these carts, establish the necessary criteria, that meets your facility needs:
    Meets battery standards for use in a hospital enviro­nment
    Preventative and mainte­nance documents to be supplied to facilities
    Contact manufa­cturer support with all questions

Reporting Problems to the FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you experience adverse events we encourage you to file a voluntary report through MedWatch, the FDA Safety Inform­ation and Adverse Event Reporting program. Provide the following inform­ation:
How was the cart or battery charger being used at the time of the event
Any patient, staff, or visitor injuries and or any actions taken by the facility
What type of event occurred, i.e., explosion, fire, smoke
Any cart identi­fiers, i.e., manufa­cturer name, model number
Any action taken by the cart system manufa­cturer and your facility.

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