Model Number CR2 |
Device Problem
Failure to Deliver Shock/Stimulation (1133)
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Patient Problem
Ventricular Fibrillation (2130)
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Event Date 04/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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Physio-control contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.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 indicated a shockable rhythm during the first four analyses, yet the charge was removed each time.There was patient involvement the issue caused a delay in the provision of defibrillation while the patient was in a life-threatening cardiac rhythm.
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Event Description
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The customer contacted physio-control to report that their device indicated a shockable rhythm during the first four analyses, yet the charge was removed each time.There was patient involvement the issue caused a delay in the provision of defibrillation while the patient was in a life-threatening cardiac rhythm.
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Manufacturer Narrative
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Physio-control reviewed the device data and verified the reported issue.It was determined the issue was traced to the user and no device malfunction occurred.
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Search Alerts/Recalls
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