Model Number CR2 |
Device Problems
Failure to Analyze Signal (1539); No Audible Prompt/Feedback (2282)
|
Patient Problem
Cardiac Arrest (1762)
|
Event Date 09/17/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Physio-control contacted the customer to request additional information on the patient.The customer provided physio-control with the available patient information.Patient fields in which information is not provided were intentionally left blank. a clinical review was performed and in the medical judgment of the reviewers, it is unknown if the device caused or contributed to the patient's outcome.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.
|
|
Event Description
|
The customer contacted physio-control to report that their device failed to provide audio prompts and complete an ecg analysis.The patient did not survive the event.
|
|
Event Description
|
The customer contacted physio-control to report that their device failed to provide audio prompts and complete an ecg analysis.The patient did not survive the event.Upon further communication with the customer they indicated no device failure occurred.
|
|
Manufacturer Narrative
|
The customer informed physio-control that the issue has been resolved, and the device does not need to be returned for further evaluation.Per the customer the device was operating as intended and there was no evidence of malfunction.
|
|
Search Alerts/Recalls
|