MAUDE Adverse Event Report: MASIMO CORPORATION RAINBOW ADH SENSOR R1 20L, INF, 10/BOX

Model Number 24960

Device Problem 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

It was reported that the pouches have a new illustration.The new illustration appears to show the cable running along the bottom rather than the top of the foot.Also, the hand illustration shows the cable on the side of thumb.The illustration only shows the placement which is appropriate for pts 3 to 10kg.The dfu for this device recommends using fingers for application in pts 10 to 30kg.

• Brand Name: RAINBOW ADH SENSOR R1 20L, INF, 10/BOX
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery ; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI, S.A.
• Manufacturer Contact: charlene johnson ; 52 discovery ; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4987653
• MDR Text Key: 22464473
• Report Number: 2031172-2015-00977
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• 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: Other
• Device Expiration Date: 04/01/2018
• Device Model Number: 24960
• Device Catalogue Number: 2415
• Device Lot Number: A15D105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DRAEGER MONITOR M540