|
Model Number PM35MN02 |
Device Problem
Material Integrity Problem (2978)
|
Patient Problem
Cyanosis (1798)
|
Event Date 03/01/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during use, the patient was desaturated to 54% for 3 minutes and the device did not alarm.It was also stated that the device was previously shown a white screen and power cycled by itself causing to be disconnected from vital sync not to be alarmed also.The patient looked blue or cyanotic when found out.
|
|
Manufacturer Narrative
|
Additional info: date received by mfr, device evaluated by mfr, evaluation codes.Evaluation summary: one sample was received for evaluation.No fault was found in the monitor operation.The alarms were set to disable and thus did not provide the notification during the event.The monitor has shown to be operating correctly under the alarm settings that have been set through the institutional defaults.The monitor is recording the trends and providing information on saturation and pulse rate as expected.The investigation found the device to function normally.Information has been added to the database and trends will continue to be monitored.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|