MAUDE Adverse Event Report: MASIMO - 40 PARKER PATIENT SAFETYNET SYSTEM; SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS

Model Number 9095

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 03/14/2017

Event Type  Death  

Manufacturer Narrative

Remote troubleshooting of the system was performed.It was found that the bedside instrument was removed from the system as part of the protocol.The instrument was added to safetynet, and the report was accessible.The safetynet system was determined to be functioning as designed., corrected data:.

Event Description

It was reported that the patient report data is not showing for one specific patient only.This patient passed away recently (on (b)(6) 2017).Patient was admitted into the system on (b)(6) 2016 and discharged from the system on (b)(6) 2017.Customer confirms that they are entering a date and time range that begins on or before (b)(6).Several different ranges were entered to try and find data for the specific patient.This patient in question, along with a few other patients, show up on the report list for the different ranges that are entered.When the report is generated for the patient in question, there is no data.However, the other patients on the list do have data when their report is generated.Customer confirms that all patient categories are checked off.Customer confirmed that they are only trying to generate a general patient report, not a specific patient trend analysis.Customer states they are trying to generate the report from the same computer that the safetynet program is on.Safetynet version: (b)(4).All bedside monitors were working fine.

• Brand Name: PATIENT SAFETYNET SYSTEM
• Type of Device: SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS
• Manufacturer (Section D): MASIMO - 40 PARKER; 40 parker; irvine CA 92618 1604
• 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: 6455576
• MDR Text Key: 71576551
• Report Number: 2031172-2017-00395
• Device Sequence Number: 1
• Product Code: MSX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9095
• Device Catalogue Number: 9095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/14/2017
• 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
• Patient Outcome(s): Death