MAUDE Adverse Event Report: MASIMO CORPORATION LNCS DC-I; OXIMETER

Model Number 1863

Device Problem Packaging Problem (3007)

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

Event Date 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

The returned device was evaluated and was confirmed as non-masimo product.Unfortunately, there is insufficient information to conclusively determine whether the returned sensor was packaged inside of a masimo box or not.A device history record (dhr) review was performed and there were no non-conformances identified during the manufacturing process.

Event Description

It was reported by the customer that they received a non-masimo sensor inside a masimo package.There is no report of any patient impact or consequence as a result of the issue.

• Brand Name: LNCS DC-I
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; 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 ; 9492977000
• MDR Report Key: 5412337
• MDR Text Key: 37525759
• Report Number: 2031172-2016-00118
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Biomedical Engineer
• Device Model Number: 1863
• Device Catalogue Number: 1863
• Device Lot Number: K15NFJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1