|
Model Number HL-90 |
Device Problem
Defective Alarm (1014)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/01/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
No information has been provided to date.H3 - other: device has not been returned to date.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 was not alarming, found during routine preventative maintenance testing.No patient involvement and no harm/adverse event reported.
|
|
Search Alerts/Recalls
|
|
|