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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RAD-5 PULSE OXIMETER
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MASIMO - 40 PARKER RAD-5 PULSE OXIMETER Back to Search Results
Model Number 25198
Medical Device Problem Code Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/12/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.External visual inspection showed no damage.When powered on, some led segments did not illuminate.Alarm alert conditions were functional with visual and audio status indicators.Internal inspection showed two led segments on the instrument board had failed.A service history record review reveals that this unit was in the field for over one (1) year with no previous reported issues related to this reported event.
 
Event or Problem Description
The customer reported the top of the display is missing segment lines.No patient impact or consequences were reported.
 
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Brand Name
RAD-5 PULSE OXIMETER
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key8396372
Report Number2031172-2019-00111
Device Sequence Number2978401
Product Code DQA
UDI-Device Identifier00843997005517
UDI-Public00843997005517
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K033296
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) 02/12/2019
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 Number25198
Device Catalogue Number9196
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2019
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2019
Initial Report FDA Received Date03/06/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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