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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MASIMO - 40 PARKER USP02 OXIMETRY CABLE; OXIMETER

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MASIMO - 40 PARKER USP02 OXIMETRY CABLE; OXIMETER Back to Search Results
Model Number 3450
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/02/2017
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to masimo for evaluation.When the investigation is complete a follow up report will be submitted.
 
Event Description
It was reported that "cables no longer function".Additional information received from customer, "the cables failed during use and that the issue that they are failing to transmit data".No known impact or consequence to patient.
 
Manufacturer Narrative
Additional manufacuring narrative: other, additional manufacturing narrative (if other): the returned cable was evaluated.During evaluation the cable was found to be missing the latch.There was light at the sensor, but it was not able to get a measurement.It was determined that there was a defective component in the bic causing the cable not to function as expected.X-ray investigation revealed no visible anomalies therefore the exact failed component could not be determined.
 
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Brand Name
USP02 OXIMETRY CABLE
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 Key6356733
MDR Text Key68278935
Report Number2031172-2017-00250
Device Sequence Number1
Product Code DQA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121914
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Biomedical Engineer
Remedial Action Other
Type of Report Initial,Followup
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 Number3450
Device Catalogue Number9477
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 02/02/2017
Initial Date FDA Received02/24/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2016
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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