The reported event was reproduced during functional testing and confirmed through archive data review of the autopulse lithium ion battery ((b)(4)).The battery was received with no physical damage with two amber leds illuminated on the battery status indicator.The battery was functionally tested by inserting into a good known reference autopulse multi chemistry charger (mcc) and the mcc illuminated a red battery charger led indicating that the mcc was unable to charge the battery.Review of the retrieved archive data revealed that the battery was left inside the autopulse platform for an extended period of time staring on (b)(6) 2017 for 12.2 days without being recharged in the mcc.The battery entered into preserved mode and displayed multiple battery errors related to an electro static discharge (esd).Following this the battery was reconditioned once properly charged into an mcc and became operational.Starting on (b)(6) 2017, the battery sat idle and uncharged for 74.3 days until being reconditioned in the mcc.On (b)(6) 2018, the battery was inserted in an autopulse platform and recorded multiple elevated temperature readings on the battery thermistor and multiple battery errors.The autopulse power system user guide states that "after every use, at the beginning of a shift, or at least once every 24 hours, the battery in the autopulse should be replaced with a fully charged battery." a fully charged autopulse lithium ion battery left in a zoll autopulse platform for an extended period of time will eventually discharge below its minimum operating voltage.A fully discharged battery will not display any led status lights and will not be able to charge in the mcc.
|
During routine testing, a fully charged autopulse li-ion battery ((b)(4)) (with four green leds illuminated on the battery status indicator) was inserted in an autopulse platform.The platform was unable to power on.Following this the platform was tested using another battery and powered on, operating as expected.The battery ((b)(4)) was inserted in an autopulse multi chemistry charger (mcc) and was unable to successfully charge.The mcc displayed a red charger led.No patient involvement.
|