Model Number 22042 |
Device Problems
Device Alarm System (1012); Incorrect Measurement (1383)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/04/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
|
|
Event Description
|
The customer reported the device keeps alarming and is not reading accurately.No patient impact or consequences were reported.
|
|
Event Description
|
The customer reported the device keeps alarming and is not reading accurately.No patient impact or consequences were reported.
|
|
Manufacturer Narrative
|
Additional manufacuring narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.
|
|
Search Alerts/Recalls
|