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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO CORPORATION RADIUS-7; OXIMETER
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MASIMO CORPORATION RADIUS-7; OXIMETER Back to Search Results
Model Number 24970
Device Problems Image Reversal (1358); Incorrect Measurement (1383)
Patient Problem No Patient Involvement (2645)
Event Date 03/19/2015
Event Type  malfunction  
Event Description
It was reported that the device gives inaccurate readings.The unit has a mirror effect.For an example, if the pulse rate of the subject is 89, the screen displays 98.Add'l info rec'd indicated that the device was not tested on a pt.The mirror effect does not only include the pulse rate reading of the device.The whole screen has the mirror effect.No pt involvement.
 
Manufacturer Narrative
The prod has been returned to masimo for eval.When the investigation is complete a f/u report will be submitted.
 
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Brand Name
RADIUS-7
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO CORPORATION
40 parker
irvine CA 92618
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI SA
Manufacturer Contact
charlene johnson
40 parker
irvine, CA 92618
9492977000
MDR Report Key4714161
MDR Text Key5665184
Report Number2031172-2015-00668
Device Sequence Number1
Product Code MWI
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24970
Device Catalogue Number24970
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/03/2015
Is the Reporter a Health Professional? No
Date Manufacturer Received03/20/2015
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
MASIMO ACOUSTIC SENSOR; MASIMO RAINBOW SET SENOR
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