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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO PATIENT SAFETY NET
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MASIMO CORPORATION MASIMO PATIENT SAFETY NET Back to Search Results
Model Number PSN
Device Problems Unable to Obtain Readings (1516); Output Problem (3005)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/24/2014
Event Type  malfunction  
Event Description
Customer reported that "masimo (oxygen monitoring) main screen and pt screen showed no readings.Cord replaced and most likely defective." no patient incident reported.
 
Manufacturer Narrative
The customer facility name and contact information was not available.The unit was not returned to allow an analysis to be performed.If new information is obtained, a follow up report will be submitted.No patient incident reported.This is a follow up to the user facility report submitted and received by masimo.(b)(4).
 
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Brand Name
MASIMO PATIENT SAFETY NET
Manufacturer (Section D)
MASIMO CORPORATION
40 parker
irvine CA 92618
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C.V.
calzada del oro no. 2001
parque industrial palaco
Manufacturer Contact
jodi swindle
40 parker
irvine, CA 92618
9492977000
MDR Report Key4081106
MDR Text Key4827251
Report Number2031172-2014-00171
Device Sequence Number1
Product Code MSX
Combination Product (y/n)N
PMA/PMN Number
K071047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Type of Report Initial
Report Date 07/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberPSN
Was Device Available for Evaluation? No
Date Manufacturer Received07/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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