Catalog Number 21-2112-0402-51 |
Device Problem
Device Alarm System (1012)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/01/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
B3: date of event is unknown.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
|
|
Event Description
|
It was reported that the device had a system error 41100.The product fault occurred upon power on.There was no patient involvement, and no harm/adverse event was reported.
|
|
Manufacturer Narrative
|
One device was received for evaluation.Visual inspection found a lifted dso seal, and a worn uso seal.There was no evidence in the event history log.Functional testing was unable to verify or duplicate the reported problem.The dso and uso seal were replaced.The service history review had no indication that the complaint was related to a service of the device within the review period.
|
|
Search Alerts/Recalls
|