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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 Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 11/01/2017
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 the nursing home was monitoring the hb status of an anemic patient, who has needed blood transfusions in the past, using the pronto monitor.Pronto was reading the patient at 13-14 g/dl.Questioning the pronto readings, the don then performed an (b)(6) test and the results showed patient was at 5-6 g/dl.
 
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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 Key7145286
Report Number2031172-2017-01099
Device Sequence Number939815
Product Code DQA
UDI-Device Identifier00843997008921
UDI-Public00843997008921
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K091057
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Remedial Action Other
Type of Report Initial
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? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/29/2017
Initial Report FDA Received Date12/24/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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