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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER O3 REGIONAL OXIMETER MODULE
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MASIMO - 40 PARKER O3 REGIONAL OXIMETER MODULE Back to Search Results
Model Number 9637
Medical Device Problem Code Incorrect Measurement (1383)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Attempts for the return of the product as well as additional information requests have been made in order to identify the product involved in the reported event.The customer indicated that the product used for this event was discarded and the lot/serial number was not available.If new information is obtained, a follow-up report will be submitted device not returned.
 
Event or Problem Description
The customer reported inaccurate values during a lung transplant, a difference was seen between the left and the right so2.No patient impact or consequences were reported.
 
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Brand Name
O3 REGIONAL OXIMETER MODULE
Common Device Name
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
MDR Report Key8646223
Report Number2031172-2019-00268
Device Sequence Number1992808
Product Code MUD
UDI-Device Identifier00843997010771
UDI-Public00843997010771
Combination Product (Y/N)N
Initial Reporter CountryNL
PMA/510(K) Number
K160526
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date (Section B) 05/08/2019
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 Model Number9637
Device Catalogue Number9637
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 05/08/2019
Initial Report FDA Received Date05/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ROOT; SEDLINE SENSOR
Patient Age3 YR
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