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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO CORPORATION RAD-8, HORIZONTAL
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MASIMO CORPORATION RAD-8, HORIZONTAL Back to Search Results
Model Number 9224
Device Problems Device Displays Incorrect Message (2591); Improper Device Output (2953)
Patient Problem No Patient Involvement (2645)
Event Date 08/01/2014
Event Type  malfunction  
Event Description
It was reported that the unit is alarming when it is not supposed to and that units are reading spo2 incorrectly.No patient was involved with this incident.
 
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
RAD-8, HORIZONTAL
Manufacturer (Section D)
MASIMO CORPORATION
40 parker
irvine CA 92618
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C.V.
calzada del oro no. 2001
parque industrial palaco
Manufacturer Contact
jodi swindle
40 parker
irvine, CA 92618
9492977000
MDR Report Key4081084
MDR Text Key4827784
Report Number2031172-2014-00156
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 08/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number9224
Device Catalogue Number9224
Other Device ID Number22595
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/07/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received07/30/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2011
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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