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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY RAD-5 PULSE OXIMETER
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MASIMO - 52 DISCOVERY RAD-5 PULSE OXIMETER Back to Search Results
Model Number 26818
Medical Device Problem Codes Incorrect Measurement (1383); Unable to Obtain Readings (1516)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/23/2020
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 the rad-5 is not monitoring correctly.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 - 52 DISCOVERY
52 discovery
irvine CA 92618
MDR Report Key11527783
Report Number3011353843-2021-00069
Device Sequence Number14766826
Product Code DQA
UDI-Device Identifier00843997005517
UDI-Public00843997005517
Combination Product (Y/N)N
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 02/23/2021
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 Number26818
Device Catalogue Number9196
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 02/23/2021
Initial 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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