MAUDE Adverse Event Report: TIJUANA-RX NELLCOR; NEO/ADULT OXY SENSOR MDL MAXNI

Model Number MAXNI

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient information (id, age, sex, weight) as well as additional information associated with the complaint have been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.

Event Description

The customer reported the device screen indicated oxygen saturation of 99% however the physician had a doubt and checked by blood gas samples.The blood gas result said: 89%, a 10point difference.There was no harm to the patient and there was no required intervention reported.Additional information has been requested.

• Brand Name: NELLCOR
• Type of Device: NEO/ADULT OXY SENSOR MDL MAXNI
• Manufacturer (Section D): TIJUANA-RX; blvd. insurgentes parcela #37; tijuana, bc ; MX
• Manufacturer (Section G): COVIDIEN; blvd. insurgentes parcela #37; tijuana, bc ; MX
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6003051
• MDR Text Key: 57251168
• Report Number: 2936999-2016-00785
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 09/09/2016

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 Number: MAXNI
• Device Lot Number: R1608837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1