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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-5V PULSE OXIMETER
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MASIMO - 40 PARKER RAD-5V PULSE OXIMETER Back to Search Results
Model Number 25199
Medical Device Problem Code Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/20/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The actual device was evaluated.Visual inspection revealed no external damages.The device was able to obtain readings.The device was disassembled and no loose cabling or loose circuit board to circuit board interconnections observed.The led segments on the led digits did not illuminate on start up.The failed led segment on the instrument circuit board failed voltage inspection.A service history record review reveals that this unit was in the field for almost two (2) years with no previous reported issues related to this reported event.
 
Event or Problem Description
The customer reported one of the led bars for bpm is missing.No impact or consequences to patient was reported.
 
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Brand Name
RAD-5V PULSE OXIMETER
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key7775647
Report Number2031172-2018-00428
Device Sequence Number1319342
Product Code DQA
UDI-Device Identifier00843997005524
UDI-Public00843997005524
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K033998
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Biomedical Engineer
Remedial Action Other
Type of Report Initial
Report Date (Section B) 07/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number25199
Device Catalogue Number9197
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/27/2018
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/20/2018
Initial Report FDA Received Date08/12/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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