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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO SPO2 UPGRADE KIT PANDA/GIRAFE; OXIMETER
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MASIMO CORPORATION MASIMO SPO2 UPGRADE KIT PANDA/GIRAFE; OXIMETER Back to Search Results
Model Number 18394
Device Problem Incorrect Or Inadequate Test Results (2456)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/06/2014
Event Type  malfunction  
Event Description
It was reported that ge panda warmer with masimo upgrade kit had difficulty with obtaining readings for spo2 and pulse rate.No known pt impact was reported.
 
Manufacturer Narrative
Attempts for product return and requests for add'l info were made.The unit has not been returned to masimo to allow an analysis to be performed.If new info is obtained or the device is returned, a f/u report will be submitted.
 
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Brand Name
MASIMO SPO2 UPGRADE KIT PANDA/GIRAFE
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO CORPORATION
40 parker
irvine CA 92618
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI S. A.
MX  
Manufacturer Contact
michelle andres
40 parker
irvine, CA 92618
9492977000
MDR Report Key4254177
MDR Text Key19355950
Report Number2031172-2014-00378
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/07/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number18394
Device Catalogue NumberMA
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
GE PANDA INFANT WARMER WITH; MASIMO SET BOARD
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