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

Model Number 9095

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/15/2016

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 evaluation or new information is obtained, a follow up report will be submitted.

Event Description

It was reported that "masimo cs was called into patient room due to wrong patient information displayed on the root device.The nurse reported that she attempted to discharge the patient from the root but was unsuccessful.Cs verified patient information on the root device in 406a matched the patient who was located in room 403b.Cs went to safetynet view, clicked on 406a to go into detail view.Patient information on the detail view matched the patient physically located in 406a.(patient information was different at the bedside than at the safetynet view).Cs verified the sn configured in safetynet for room 406a matched the device physically located in room 406a.The cs asked the nurse to check the adt system to verify patient location in adt.The patient physically located in 403b was admitted to 403b in the adt system.The patient physically located in 406a was admitted to 406a in the adt system.Masimo cs discharged the patient from the safetynet view and re-admitted using the ¿import¿ function.Cs verified the patient physically located in room 406a matched the patient information for the monitor in 406a displayed on the safetynet view.Masimo cs went to the bedside to verify patient information on the root; it matched the patient information for the patient in room 403b.Masimo cs attempted to discharge the patient from the root in 406a but was unsuccessful.There was no error message.The ¿confirm¿ button was pressed upon prompting, but the screen reverted back to the patient information screen which continued to display the patient information from the patient admitted to room 403b.Masimo cs performed a full power cycle.Upon start-up and following the full power cycle, the correct patient information was displayed on the root.When the cs left room 406a, a different nurse reported they were unable to discharge the patients from room 427a and 429a.When they attempted to discharge, they noticed the patient information in both rooms matched the patient information from room 403b.When masimo cs arrived in rooms 427a & 429a, the issue had resolved, the patient information was accurate and the nurse was able to discharge from the patient from root".No known impact or consequence to patient.

Manufacturer Narrative

Masimo was on-site and updated the software which addressed the issues.The safetynet system is functioning as designed., corrected data: brand name was "root" should be "patient safety net system" procode was "dqa" should be "msx".Model # and catalog # was "9515" should be "9095" pma/510(k) # was "k140188" should be "k071047".

• Brand Name: PATIENT SAFETY NET 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: 6231974
• MDR Text Key: 64132863
• Report Number: 2031172-2017-00038
• 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: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9095
• Device Catalogue Number: 9095
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/23/2017
• 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
• Treatment: PATIENT SAFETY NET SYSTEM