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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RD RAINBOW SET R25-12; OXIMETER
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MASIMO - 52 DISCOVERY RD RAINBOW SET R25-12; OXIMETER Back to Search Results
Model Number 4078
Medical Device Problem Codes Sensing Intermittently (1558); Material Separation (1562)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/1901
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The product has been returned to the local facility but has not yet been received at the main office for evaluation.Once returned and investigated, a follow-up report will be submitted.
 
Event or Problem Description
The customer reported that the wire is bare at the connection and measurements are interrupted.No consequences or impact to patient were reported.
 
Event or Problem Description
The customer reported that the wire is bare at the connection and measurements are interrupted.No consequences or impact to patient were reported.
 
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Brand Name
RD RAINBOW SET R25-12
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11236224
Report Number3011353843-2021-00013
Device Sequence Number3500474
Product Code DQA
UDI-Device Identifier00843997010665
UDI-Public00843997010665
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K042536
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date (Section B) 01/04/2021
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 Number4078
Device Catalogue Number4078
Device Lot Number18H97
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/04/2021
Supplement Date Received by Manufacturer02/26/2021
Initial Report FDA Received Date01/27/2021
Supplement Report FDA Received Date03/19/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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