Model Number 20E |
Device Problem
Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Due to character limitations section e1, initial reporter phone, was left blank.The initial reporter¿s phone number is (b)(6).Stryker continues to investigate the reported failure 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 stryker to report that their device stuck at "connect electrodes".In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient involvement reported with the event.
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Manufacturer Narrative
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Stryker evaluated the customer¿s device and was unable to duplicate the reported issue.Stryker downloaded the electronic records from the customer¿s device and was able to confirm the reported issue.After observing proper device operation through functional and performance testing the unit was returned to the customer for use.The cause of the reported issue could not be determined.
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Event Description
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The customer contacted stryker to report that their device stuck at "connect electrodes".In this state the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient involvement reported with the event.
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Search Alerts/Recalls
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