Model Number 10005941J |
Device Problem
Defective Component (2292)
|
Patient Problems
Death (1802); Insufficient Information (4580)
|
Event Date 09/04/2020 |
Event Type
Death
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, use of the device was terminated when the patient passed away.There was no allegation against the device in relation to the patient death.Subsequent routine servicing of the device replaced the battery, jog dial and the main body was upgraded.
|
|
Manufacturer Narrative
|
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the jog dial on the monitor needed to be replaced and the battery failed but was due to normal usage.The issue was resolved by replacing the jog dial and battery.It was reported that the jog dial on the pulse ox monitor needed to be replaced.The reported issue was confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, the unit's jog dial was damaged.The units used was terminated because the patient passed away.There was no allegation against the monitor in relation to the patient death.
|
|
Search Alerts/Recalls
|