Model Number 20E |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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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The customer contacted physio-control to report that their device displayed a white screen upon power on.This is an indication that the device may be inoperable and defibrillation therapy would not be available if 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 was returned stryker india, but has not been returned to stryker redmond for evaluation, due to local shipping regulations.Stryker verified the reported issue from a photo the customer provided.The cause of the reported issue could not be determined.The returned device was archived by stryker and a replacement device was sent to the customer.H3 other text : device not accessible for testing.
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Event Description
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The customer contacted physio-control to report that their device displayed a white screen upon power on.This is an indication that the device may be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
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Event Description
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The customer contacted physio-control to report that their device displayed a white screen upon power on.This is an indication that the device may be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
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Manufacturer Narrative
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Stryker redmond further evaluated the customer¿s device and verified the reported issue.Stryker determined that cause of the reported issue was due to capacitor, designator c181.C181 was cracked and electrically shorted.The returned device was archived by stryker redmond.
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Search Alerts/Recalls
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