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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO CORPORATION RAD-8; OXIMETER
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MASIMO CORPORATION RAD-8; OXIMETER Back to Search Results
Model Number 20877
Device Problem Electro-Static Discharge (2149)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/10/2014
Event Type  malfunction  
Event Description
It was reported that there was an electrical hazard when using the device for monitoring.The term used was "risque esd" which was translated as esd risk: "electrostatic discharge".Additional clarification received from the customer: "saturation passes on current to the patient." no known consequences or impact to patient.
 
Manufacturer Narrative
The product 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
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
michelle andres
40 parker
irvine, CA 92618
9492977000
MDR Report Key4421215
MDR Text Key5377307
Report Number2031172-2015-00016
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
PMA/PMN Number
K092838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 12/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number20877
Device Catalogue Number9190
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/24/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received12/10/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2007
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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