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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-8, HORIZONTAL; OXIMETER
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MASIMO - 40 PARKER RAD-8, HORIZONTAL; OXIMETER Back to Search Results
Model Number 22042
Device Problem Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/26/2018
Event Type  malfunction  
Manufacturer 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., corrected data:.
 
Event Description
The customer reported: "rad-8 is giving intermittent readings." no patient impact or consequences were reported.
 
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Brand Name
RAD-8, HORIZONTAL
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 Key7279522
MDR Text Key100527458
Report Number2031172-2018-00097
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 company representative,distri
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 Received02/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number22042
Device Catalogue Number9190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received01/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/13/2016
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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