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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-8; OXIMETER
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MASIMO - 40 PARKER RAD-8; OXIMETER Back to Search Results
Model Number 22042
Device Problem No Audible Alarm (1019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2017
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.
 
Event Description
The customer reported "faulty alarms".No known impact or consequence to patient was reported.
 
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Brand Name
RAD-8
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
stefan lissmann
52 discovery
irvine, CA 92618-1604
9492977000
MDR Report Key6753137
MDR Text Key81381977
Report Number2031172-2017-00757
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 Health Professional
Remedial Action Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2017
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 Manufacturer07/13/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received07/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/22/2016
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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