Model Number 1000 |
Device Problem
Premature Discharge of Battery (1057)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Physio control evaluated the customers device and verified the reported issue.The device and the battery will be sent for a further investigation to the pac (product analysis center).A customer will receive a replacement.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
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Event Description
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A customer contacted stryker to report that their device had experienced sudden battery depletion.Upon initial evaluation, stryker observed that the downloaded data showed that the device's battery had suddenly depleted during its daily automated self-test.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no patient use associated with the reported event.
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Manufacturer Narrative
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The customer's device and battery were further evaluated by stryker.It was observed that the battery was approximately 4 years old.The pac verified that the customer's battery was indeed depleted.No excessive off current was measured from the device.A new non rechargeable battery has a shelf life of five years if stored at the proper conditions.The battery (stored outside the defibrillator) self-discharges over time; therefore, when the battery is eventually placed in the defibrillator, its useful life will be reduced depending on how long it was stored.The depleted battery was verified, however a conclusive cause of the reported issue could not be determined.
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Event Description
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A customer contacted stryker to report that their device had experienced sudden battery depletion.Upon initial evaluation, stryker observed that the downloaded data showed that the device's battery had suddenly depleted during its daily automated self-test.In this state, the device may not be able to provide defibrillation therapy, if it were needed.There was no patient use associated with the reported event.
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Search Alerts/Recalls
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