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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 No Audible Alarm (1019)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2016
Event Type  malfunction  
Manufacturer Narrative
The returned device was evaluated.During evaluation the unit was able to power on, however, no audible alarms or sounds were heard.Visual inspection revealed that the speaker wires on both the front and top speakers were detached.This failure prevented the audible alarms from being heard.The speaker was replaced and the device functioned as designed.
 
Event Description
It was reported that the device does not alarm.No consequences or impact to patient.
 
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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 92618-1604
9492977000
MDR Report Key5587130
MDR Text Key43017018
Report Number2031172-2016-00502
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 health professional,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 03/30/2016
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 Manufacturer04/07/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/30/2016
Initial Date FDA Received04/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/19/2014
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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