Skip NavigationFDA Logo links to FDA home pageCenter for Devices and Radiological Health, U.S. Food and Drug AdministrationHHS Logo links to Department of Health and Human Services website

FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH U.S. Food and Drug Administration Center for Devices and Radiological Health
horizonal rule

Medical Device Safety

Graphic of a wall outlet with a plug in itSafety Tip - Plug it in!

Problem Description:

Many portable devices are designed to operate either on battery or from a wall outlet. When not in transport, these devices should be plugged in to ensure full charge on the battery and to avoid power loss due to battery depletion.

Use/Design issues:

It is not always easy to determine whether these devices are plugged in; many users operate the devices assuming they are plugged into a live electrical outlet. Even when users know they are operating on batteries they might not be able to easily assess how much charge is left on the battery, how long that charge will last, when to charge, or for how long. There can often be a relatively short time between the low battery alarm warning and the failure of the device. Serious adverse events may also occur when electrode leads and power cords are mistakenly plugged into a live electrical outlet.

Reported MedSun Incidents:

  • “Continuous doppler was used to monitor circulation to the surgical site post operatively. Instead of being plugged in, the device was running on battery power. The battery ran low and the doppler stopped. There was no reported injury to the patient.”
  • “A patient was receiving epinephrine drip via syringe pump. Rechargeable batteries were relied on to supply power, rather than plugging the device into to AC power. After thirty minutes, the pump stopped and the patient became hypotensive.”

Staff intervened in each of these power losses and avoided serious injury to their patients. The risk of injury can be considerably reduced by ensuring that a device is plugged into the appropriate power source and that equipment is not run on battery power unless necessary.

Facility Portable Battery Device Checklist:

Plugged in—
___ Is an appropriate power cord for this device available?
___ Is the correct end of the power cord plugged into the device and a wall outlet?
___ Do you know your facility’s policy on cables and leads?

Battery Maintenance—
___ Is there a schedule in place to recharge and monitor battery charge?
___ Is the battery charged sufficiently for the period of time that battery power will be used?
___ Are staff aware of the short lead time between a low battery warning alarm and power failure?
___ Do staff monitor device displays to ensure battery power is not being used inadvertently?

horizonal rule

CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page

Center for Devices and Radiological Health / CDRH

Web page updated by OSM/SWDB 2003-MAY-29