Model Number CRPLUS |
Device Problems
Failure to Power Up (1476); Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/05/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Physio-control performed an initial evaluation of the customer¿s device but was unable to verify the reported ecg issue, due to the device being unable to power on.Physio-control continues to investigate the reported issue 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 intermittently was unable to detect an ecg rhythm.Upon evaluation of the customer¿s device, physio-control observed that the device displayed the attention and service wrench icons and was unable to power on.There was no patient use associated with this event.
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Manufacturer Narrative
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Physio-control was unable to verify the reported ecg issue, but confirmed that the device was unable to power on.The device could not be repaired and was removed from service.The customer was contacted regarding replacing their device.The cause of the reported and observed issues could not be determined.
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Event Description
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The customer contacted physio-control to report that their device intermittently was unable to detect an ecg rhythm.Upon evaluation of the customer¿s device, physio-control observed that the device displayed the attention and service wrench icons and was unable to power on.There was no patient use associated with this event.
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Search Alerts/Recalls
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