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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RADICAL-7 HANDHELD; OXIMETER
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MASIMO - 40 PARKER RADICAL-7 HANDHELD; OXIMETER Back to Search Results
Model Number 25054
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.
 
Event Description
The customer reported that the device continuously shuts down.No consequences or impact to patient were reported.
 
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Brand Name
RADICAL-7 HANDHELD
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
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
erica kline
52 discovery
irvine, CA 92618-1604
9492977000
MDR Report Key7103296
MDR Text Key94550068
Report Number2031172-2017-01080
Device Sequence Number1
Product Code DQA
UDI-Device Identifier00843997008358
UDI-Public00843997008358
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number25054
Device Catalogue Number9500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2017
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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