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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER RD RAINBOW SET-2 INF; OXIMETER
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MASIMO - 40 PARKER RD RAINBOW SET-2 INF; OXIMETER Back to Search Results
Model Number 4028-9
Medical Device Problem Code High Readings (2459)
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
Attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.Device not returned.
 
Event or Problem Description
The customer reported that the device provided high readings.No consequences or impact to patient were reported.
 
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Brand Name
RD RAINBOW SET-2 INF
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key8746439
Report Number2031172-2019-00316
Device Sequence Number11404522
Product Code DQA
UDI-Device Identifier10843997010921
UDI-Public10843997010921
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K042536
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 06/07/2019
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 Expiration Date03/01/2022
Device Model Number4028-9
Device Catalogue Number4028
Device Lot Number19CUR
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/07/2019
Initial Report FDA Received Date06/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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