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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER MASIMO SENSOR; OXIMETER
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MASIMO - 40 PARKER MASIMO SENSOR; OXIMETER Back to Search Results
Device Problem Device Stops Intermittently (1599)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/01/2018
Event Type  malfunction  
Manufacturer Narrative
Additional manufacturing narrative: attempts for the return of the sensor as well as additional information requests have been made in order to identify the sensor involved in the reported event.The customer indicated that the sensor used for this event was discarded and the sensor lot information was not available.If new information is obtained, a follow-up report will be submitted.
 
Event Description
The customer reported spo2 reading drop outs.No patient impact or consequences were reported.
 
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Brand Name
MASIMO SENSOR
Type of Device
OXIMETER
Manufacturer (Section D)
MASIMO - 40 PARKER
40 parker
irvine CA 92618 1604
Manufacturer (Section G)
INDUSTRIAL VALLERA DE MEXICALI S.A DE C.V.
calzada del oro, no. 2001
parque industrial palaco
mexicali, baja california 21600
MX   21600
Manufacturer Contact
erica kline
52 discovery
irvine, CA 92618-1604
9492977000
MDR Report Key7401791
MDR Text Key104736931
Report Number2031172-2018-00201
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Respiratory Therapist
Remedial Action Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received03/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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