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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO CORPORATION RADICAL-7, COLOR SCREEN; OXIMETER
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MASIMO CORPORATION RADICAL-7, COLOR SCREEN; OXIMETER Back to Search Results
Model Number 23785
Device Problems Unable to Obtain Readings (1516); Improper Device Output (2953)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/15/2014
Event Type  malfunction  
Event Description
It was reported that the customer cannot read the display and it is very fuzzy.The customer stated it will engage in monitoring.No pt incident was reported.
 
Manufacturer Narrative
The device has been returned to masimo for evaluation.When the investigation is complete, a follow up report will be submitted.
 
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Brand Name
RADICAL-7, COLOR SCREEN
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO CORPORATION
40 parker
irvine CA 92618
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI, S.A.
Manufacturer Contact
jodi swindle
40 parker
irvine, CA 92618
9492977583
MDR Report Key4177398
MDR Text Key5099607
Report Number2031172-2014-00188
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 08/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number23785
Device Catalogue Number9500
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/09/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/15/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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