Model Number FM300 |
Device Problems
Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Dyspnea (1816)
|
Event Date 12/11/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.
|
|
Event Description
|
It was reported that the patient experienced slowed heart rate resulting in the need for medical intervention to return heart rate to normal.
|
|
Manufacturer Narrative
|
Product was sent to oem - wom for investigation.Three attempts have been made to retrieve the oem's investigation report and it has yet to be received.In the event that the report is received, the report will be attached to the communication log.Alleged failure: patient's heart rate slowed probable root cause: because the oem's investigation report was not provided by oem - wom, probable root cause cannot be determined.The reported failure mode will be monitored for future reoccurrence.
|
|
Event Description
|
It was reported that the patient experienced slowed heart rate resulting in the need for medical intervention to return heart rate to normal.
|
|
Search Alerts/Recalls
|