Model Number 27977 |
Device Problem
Inappropriate or Unexpected Reset (2959)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/18/2022 |
Event Type
malfunction
|
Event Description
|
The customer reported the device "auto switch on and switch off." no patient impact or consequences were reported.
|
|
Manufacturer Narrative
|
Additional manufacturing 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.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(4).
|
|
Manufacturer Narrative
|
Additional manufacturing narrative: other, other text: the returned device was evaluated.The failure analysis determined that the device powered on and off due to an electrically shorted component on the circuit board.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
|
|
Event Description
|
The customer reported the device "auto switch on and switch off".No patient impact or consequences were reported.
|
|
Search Alerts/Recalls
|