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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER M-LNCS DCI; OXIMETER

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MASIMO - 40 PARKER M-LNCS DCI; OXIMETER Back to Search Results
Model Number 2501
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/27/2017
Event Type  malfunction  
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.
 
Event Description
It was reported that spo2 does not register.Per the customer, the sensor would pick up a reading, but would go away when the patient moves.No information on error messages and/or audible alarm.No known impact or consequence to patient.
 
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Brand Name
M-LNCS DCI
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
charlene johnson
52 discovery
irvine, CA 92618-1604
9492977000
MDR Report Key6353092
MDR Text Key68145970
Report Number2031172-2017-00241
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
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
Device Operator Health Professional
Device Model Number2501
Device Catalogue Number2501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 02/02/2017
Initial Date FDA Received02/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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