Model Number 15 |
Device Problems
Failure to Charge (1085); Electrical /Electronic Property Problem (1198); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Loss Of Pulse (2562); No Known Impact Or Consequence To Patient (2692)
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Event Date 10/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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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The customer contacted physio-control to report that their device did not charge and would not respond to pressed buttons.In this state the device would be inoperable and defibrillation therapy would not be available if needed.The incident is patient related.The customer was unable to provide any patient information due to confidentiality concerns, but reported that the patient was in asystole throughout the event and did not present with a shockable rhythm at any stage of the event.
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Manufacturer Narrative
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Physio-control evaluated the customer's device and was unable to replicate the reported issue.The rear case was found to be damaged and was replaced.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing.The device 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 physio-control to report that their device did not charge and would not respond to pressed buttons.In this state the device would be inoperable and defibrillation therapy would not be available if needed.The incident is patient related.The customer was unable to provide any patient information due to confidentiality concerns, but reported that the patient was in asystole throughout the event and did not present with a shockable rhythm at any stage of the event.
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Search Alerts/Recalls
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