MAUDE Adverse Event Report: MASIMO CORPORATION RAINBOW ADH SENSOR ; OXIMETER

Model Number 24960

Device Problems Incorrect Or Inadequate Test Results (2456); Packaging Problem (3007)

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

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

Attempts have been made to obtain the product.The product involved in this event has not been returned to date to allow for an analysis to be performed.If the product is returned for eval or new info is obtained, a follow-up report will be submitted.

Event Description

The customer reported the inaccurate readings.The customer also stated the package for the rainbow r1 20l sensor incorrectly depicts sensor placement.The illustration on the package seems to show the cable, positioned on the underside of the foot.This orientation would place the emitter on the underside of the toe or thumb.The customer also, stated the illustration is not consistent with the illustration on the dfu which shows correct placement.There was no known pt impact or consequences.

Manufacturer Narrative

The initial lot number was l15bfh.However, the correct lot number should be k15bfh.

• Brand Name: RAINBOW ADH SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery ; irvine CA 92618
• 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 Key: 4987652
• MDR Text Key: 23230369
• Report Number: 2031172-2015-00975
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K0816595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24960
• Device Catalogue Number: 2415
• Device Lot Number: K15BFH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 4 MO
• Patient Weight: 8