Model Number 15 |
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 09/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The initial reporter¿s phone number is (b)(6).Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Physio-control will not request any patient identifying information to be in accordance with regulation (eu) 2016/679 of the european parliament and of the council.Physio-control 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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A customer contacted physio-control to report that their device would not recognize the electrodes being connected to the patient.As a result, defibrillation therapy would not be available, if needed.There was no harm to the patient as a result of the reported event.
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Manufacturer Narrative
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Stryker evaluated the customer's device and was unable to duplicate or verify the reported issue.After performing other unrelated repairs, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.A cause of the reported issue could not be determined.
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Event Description
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A customer contacted physio-control to report that their device would not recognize the electrodes being connected to the patient.As a result, defibrillation therapy would not be available, if needed.There was no harm to the patient as a result of the reported event.
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Search Alerts/Recalls
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