This alleged failure mode poses a low risk to the patient because the low run time of the batteries did not prevent the driver from performing its life-sustaining functions.In addition, when docked in the hospital cart, the companion 2 has a redundant power source of external wall power.The companion external li-battery packs will be returned to syncarida for evaluation.The results of the investigation will be provided in a supplemental mdr.
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The reported issue involves two companion external li-battery packs that are reported under two separate medical device reports: companion external li-battery pack s/n (b)(4) (mfr report # 3003761017-2015-00240) and companion external li-battery s/n (b)(4)(mfr report # 3003761017-2015-00242).The customer reported that when the companion hospital cart was disconnected from external wall power, the hospital cart displayed 1 minute and 40 seconds of battery run time.The customer also reported that the displayed run time jumped to 17 minutes.The customer also reported that the external batteries were switched and that the problem did not reoccur.There was no reported patient impact.Companion external battery s/n (b)(4) was returned to syncardia for evaluation.Visual inspection revealed no damage or anomalies.The external battery was connected to battery evaluation software, and it communicated as expected and exhibited no permanent faults or error flags.After the external battery was fully charged, it was docked into a companion 2 driver, and it passed all functional testing and performed as intended.There was no evidence of a device malfunction.The companion 2 driver system operator manual, at chapter 13, "power management," instructs the user that: " after disconnecting from wall power, the companion 2 driver display (counter) will take approximately one minute to update the estimated battery support time based on driver settings." the reported issue posed a low risk to the patient because it did not prevent the companion 2 driver from performing its life-sustaining functions.The companion 2 driver has redundant, alternate power sources, which include external wall power and an internal, emergency battery.In addition, all power sources are continually monitored by the companion 2 driver, with audible and visual alarms to annunciate any potential issues with the driver's power sources.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.
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