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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 22042
Device Problem False Reading From Device Non-Compliance (1228)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/06/2015
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
 
Event Description
It was reported that the rad-8 reads no sensor and the numbers kept jumping around.When it did read the sensor it would just throw random numbers.No known impact or consequence to patient was reported.
 
Manufacturer Narrative
The device involved in this event was returned for evaluation and found to have passed manual and preset simulation test.The device was able to obtain readings indicating the customer's boards are functioning as designed.No product performance issue identified related to spo2 and pulse rate.A secondary finding indicated, the silence button was identified to be worn out and does not properly depress; silence button has no physical spring back resistance so the button occasionally triggers erratically when pressed, acting as though the button is being held down.A review of the service history for this device was performed and it was concluded that the device was in the field for four (4) months with no previous returns or reported issues prior to this event.
 
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Brand Name
RAD-8
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO CORPORATION
40 parker
irvine CA 92618 1604
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.
calzada del oro, no. 2001
parque industrial palaco
mexicali, baja california 21600
MX   21600
Manufacturer Contact
charlene johnson
52 discovery
irvine, CA 92618
9492977755
MDR Report Key5321982
MDR Text Key34922581
Report Number2031172-2015-01496
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053269
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 12/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number22042
Device Catalogue Number9190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2015
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/04/2015
Initial Date FDA Received12/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2015
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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