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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAD-67 SPOT CHECK PULSE CO-OXIMETER
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RAD-67 SPOT CHECK PULSE CO-OXIMETER Back to Search Results
Model Number 27693
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/10/2021
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.
 
Event or Problem Description
The customer reported inaccurate measurements.No consequences or impact to patient were reported.
 
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Brand Name
RAD-67 SPOT CHECK PULSE CO-OXIMETER
Common Device Name
OXIMETER
MDR Report Key12642776
Report Number3011353843-2021-00275
Device Sequence Number3451484
Product Code DQA
UDI-Device Identifier00843997012812
UDI-Public00843997012812
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K040214
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 09/21/2021
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 Number27693
Device Catalogue Number9794
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 09/21/2021
Initial Report FDA Received Date10/15/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured03/26/2021
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Unknown
Patient Sequence Number1
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