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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO CORPORATION RADICAL DOCKING STATION, RDS-3; OXIMETER
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MASIMO CORPORATION RADICAL DOCKING STATION, RDS-3; OXIMETER Back to Search Results
Model Number 20874
Device Problem Image Orientation Incorrect (1305)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/08/2014
Event Type  malfunction  
Event Description
It was reported that the device's display switched from landscape to portrait mode independently.Customer also reported that the fan was louder than previous model.No known pt impact was reported.
 
Manufacturer Narrative
Multiple attempts for product return and requests for add'l info were made.The unit has not been returned to masimo to allow an analysis to be performed.If new info is obtained or the device is returned, a f/u report will be submitted.
 
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Brand Name
RADICAL DOCKING STATION, RDS-3
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO CORPORATION
40 parker
irvine CA 92618
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI, S. A.
40 parker
irvine CA 92618
Manufacturer Contact
michelle andres
40 parker
irvine, CA 92618
9492977000
MDR Report Key4254183
MDR Text Key5044431
Report Number2031172-2014-00392
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 10/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20874
Device Catalogue Number9023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received10/09/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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