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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-5V PULSE OXIMETER
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MASIMO - 52 DISCOVERY 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 09/29/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.External visual inspection showed cracked housing.The device was able to obtain readings and alarm alert conditions were functional.When powered on one led segment did not illuminate.Internal inspection isolated the failure to a detective led segment on the instrument board.The customer complaint was duplicated.A service history record review reveals that this unit was in the field for over two (2) years with no previous reported issues related to this reported event.
 
Event or Problem Description
The customer reported the device display is missing segments.No patient impact or consequences were reported.
 
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Brand Name
RAD-5V PULSE OXIMETER
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key9268908
Report Number3011353843-2019-00113
Device Sequence Number11416969
Product Code DQA
UDI-Device Identifier00843997005524
UDI-Public00843997005524
Combination Product (Y/N)N
Initial Reporter StateOK
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) 10/09/2019
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 Manufacturer10/18/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/09/2019
Initial Report FDA Received Date11/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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