MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO PT; SYSTEM, NETWORK AND COMMUNICATION

Model Number 9095

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Embolism (1829)

Event Date 09/03/2014

Event Type  Death  

Event Description

It was reported by the customer that a pt died while being monitored on the pt safety net system during the night.The pt was admitted tint the system and the alarms were noted as active at the nursing station as well as the bedside.Info was made available to masimo on (b)(6) 2014 that the pt suffered an embolism that caused alarms on both the view and the bedside monitor.

Manufacturer Narrative

The system was not returned for eval, however, a trend download was performed and the data was reviewed.Per the system configuration info the system was running in central monitoring mode.Per the trend data, the system was monitoring and generating alarms on the safety net view during the period in question as designed.

• Brand Name: MASIMO PT
• Type of Device: SYSTEM, NETWORK AND COMMUNICATION
• Manufacturer (Section D): MASIMO CORPORATION; 40 parker; irvine CA 92618
• Manufacturer (Section G): INDUSTRIAL VALLERE DE MEXICALI, S.A.
• Manufacturer Contact: ciara ignacio ; 40 parker; irvine, CA 92618 ; 9492977520
• MDR Report Key: 4156059
• MDR Text Key: 20323165
• Report Number: 2031172-2014-00235
• 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,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Date Manufacturer Received: 09/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death