Catalog Number 11996-000017 |
Device Problems
Unable to Obtain Readings (1516); Failure to Sense (1559)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The customer reported that the lot number of the chest pad is 015281 and the lot number of the side pad is 001984.Section, lot #, was intentionally left blank, as a single lot number associated with this product has not yet been identified.Physio-control contacted the customer to request additional information on the patient and concomitant lifepak device.No response has been received from the customer.Patient and product 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 they could not obtain an ecg on their lifepak 20e device.This issue is patient related; however there was no adverse event reported.
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Manufacturer Narrative
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Physio-control received additional patient information from the customer.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank.
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Event Description
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The customer contacted physio-control to report that they could not obtain an ecg on their lifepak 20e device.This issue is patient related; however there was no adverse event reported.
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Event Description
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The customer contacted physio-control to report that they could not obtain an ecg on their lifepak 20e device.This issue is patient related; however there was no adverse event reported.
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Manufacturer Narrative
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Physio-control received additional concomitant products from the customer.The customer provided physio-control with the available concomitant products.Device fields in which information is not provided were intentionally left blank.
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Event Description
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The customer contacted physio-control to report that they could not obtain an ecg on their lifepak 20e device.This issue is patient related; however there was no adverse event reported.
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Manufacturer Narrative
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Physio-control evaluated the customers device and was unable to duplicate the reported issue.The cause of the reported issue could not be determined.
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Search Alerts/Recalls
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