Model Number ALIZEA DR 1600 |
Device Problem
Problem with Software Installation (3013)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/19/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.
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Event Description
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All three devices were upgraded with blue sky software on 14th oct.Implanting the following week there was impedance warning on all 3 devices for 15 oct.The devices were not turned on at time of upgrade.There was aida statistics despite the device being turned off.Has the bluesky update commenced the aida?.
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Manufacturer Narrative
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Following an upgrade, there is a bug.The memories start just after the upgrade whereas they should start at the implantation.There will be a reset at the implantation.
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Event Description
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All three devices were upgraded with blue sky software on (b)(6).Implanting the following week there was impedance warning on all 3 devices for on (b)(6).The devices were not turned on at time of upgrade.There was aida statistics despite the device being turned off.
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Search Alerts/Recalls
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