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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER PRONTO SPOT CHECK PULSE CO-OXIMETER
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MASIMO - 40 PARKER PRONTO SPOT CHECK PULSE CO-OXIMETER Back to Search Results
Model Number 25212
Medical Device Problem Codes Incorrect Measurement (1383); Unable to Obtain Readings (1516); Device Sensing Problem (2917)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/12/2018
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
He customer reported the device provided slow readings, high readings, and no readings at all.No consequences or impact to the patient were reported.
 
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Brand Name
PRONTO SPOT CHECK PULSE CO-OXIMETER
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key8207235
Report Number2031172-2018-00599
Device Sequence Number11237928
Product Code DQA
UDI-Device Identifier00843997008921
UDI-Public00843997008921
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K091057
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date (Section B) 12/12/2018
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 Number25212
Device Catalogue Number9167
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 12/12/2018
Initial Report FDA Received Date12/31/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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