MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE INFORMATION CENTER IX; CENTRAL STATION MONITOR

Model Number 866389

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 06/20/2018

Event Type  Death  

Manufacturer Narrative

The issue is not consistent with a malfunction of the product and the customer has not alleged a malfunction.The customer requested information regarding the sequence of events that occurred involving a ecg leads off event with a patient that contributed to a delay in staff response and subsequently the noted death of the patient.The analysis of log data supports that expected ecg leads off alerts were provided and escalated to red level inop status and silencing of the alarm was performed.Resolution of the leads off issue was delayed based upon the log findings.Use of the device is considered to have been a factor in the event.

Event Description

The customer reported to philips that a patient related safety event occurred involving patient harm.On (b)(6), risk manager indicated this was a patient death.The patient was found expired in his room.The customer has not alleged a malfunction but a delay in response to the patient did occur and the customer is not sure if the device was a factor.Use of the monitoring system may have been a factor as the customer has requested detailed analysis of a leads off event and staff response via alarms/silencing.The data supports that the patient was unmonitored for a period of time.The issue occurred in bed 870a on (b)(6) 2018 between 06:00 and 07:30 am.

• Brand Name: INTELLIVUE INFORMATION CENTER IX
• Type of Device: CENTRAL STATION MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 7771687
• MDR Text Key: 116706996
• Report Number: 1218950-2018-06220
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: (01)00884838048645
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2018
• Initial Date FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 86 YR