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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO PRONTO; OXIMETER
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MASIMO PRONTO; OXIMETER Back to Search Results
Model Number 21762
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/27/2015
Event Type  malfunction  
Manufacturer Narrative
The returned device was evaluated.During evaluation the device passed all visual and functional testing.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.
 
Event Description
It was reported that the blood draw and the sensor results are four or five grams per deciliter.This has been "all over the board".There was no known impact or consequence to patient.
 
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Brand Name
PRONTO
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO
40 parker
irvine CA 92618 1604
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.
calzada del oro, no. 2001
parque industrial palaco
mexicali, baja california 21600
MX   21600
Manufacturer Contact
charlene johnson
52 discovery
irvine, CA 92618-1604
9492977000
MDR Report Key5241365
MDR Text Key31986736
Report Number2031172-2015-01324
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 10/27/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21762
Device Catalogue Number9167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received10/27/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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