MAUDE Adverse Event Report: MASIMO - 52 DISCOVERY PATIENT SAFETYNETTM SYSTEM; SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS

Model Number 24814

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

Additional manufacuring narrative: other, other text: remote troubleshooting of the system was performed.It was found that the clinical staff needed to be trained on how to properly assign primary and secondary notification device assignments during the patient admission process.The safetynet system was determined to be functioning as designed.Other text : device not returned.

Event Description

The customer reported the format for the primary and secondary naming convention had changed.With this change, the notification to the nurses (secondary notification system) were not firing.No patient impact or consequences were reported.

Manufacturer Narrative

Additional manufacturing narrative: other, other text: remote troubleshooting of the system was performed.It was found that the clinical staff needed to be trained on how to properly assign primary and secondary notification device assignments during the patient admission process.The safety net system was determined to be functioning as designed., corrected data: date of event (b3) corrected from (b)(6) 2019 to (b)(6) 2018.

Event Description

The customer reported the format for the primary and secondary naming convention had changed.With this change, the notification to the nurses (secondary notification system) were not firing.No patient impact or consequences were reported.

• Brand Name: PATIENT SAFETYNETTM SYSTEM
• Type of Device: SYSTEM, NETWORK AND COMMUNICATION, PHYSIOLOGICAL MONITORS
• Manufacturer (Section D): MASIMO - 52 DISCOVERY; 52 discovery; irvine CA 92618
• MDR Report Key: 9650337
• MDR Text Key: 179251896
• Report Number: 3011353843-2020-00012
• 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 faci
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24814
• Device Catalogue Number: 9095
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1