MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO PATIENT SAFETY NET; OXIMETER

Model Number PSN

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Information (3190)

Event Date 06/30/2014

Event Type  malfunction  

Event Description

Customer reported that "masimo cord malfunction and not reading to central station, replaced cord".No pt incident reported.Ref vol # (b)(4).

Manufacturer Narrative

The customer facility name and contact info were not available.The unit was not returned to allow an analysis to be performed.If new info is obtained, a f/u report will be submitted.No pt incident reported.This is a f/u to the user facility report submitted and received by masimo.See reference no.(b)(4).

• Brand Name: MASIMO PATIENT SAFETY NET
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERA DE MEXICALI, S. A.; MX
• Manufacturer Contact: michelle andres ; 40 parker; irvine, CA 92618 ; 9492977000
• MDR Report Key: 4268204
• MDR Text Key: 5034091
• Report Number: 2031172-2014-00403
• Device Sequence Number: 1
• Product Code: MSX
• Combination Product (y/n): N
• PMA/PMN Number: K071047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Type of Report: Initial
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PSN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1