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

Model Number 866389

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 12/25/2018

Event Type  Death  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer contacted philips with a request for retrieval of data after the death of a patient.

Manufacturer Narrative

A philips response center engineer (rce) spoke to the customer biomedical engineer (biomed).The biomed was attempting to obtain training information for the nurses.They had some strips, however, they wanted hours of general review data.There was no product malfunction, or any delay in silencing or hearing the alarms.The biomed stated the device was not a factor in the patient death.The rce assisted the biomed in obtaining the log data requested but the log data was not provided to the rce.The device remains at the customer site.No subsequent calls logged for this device/issue.No further investigation is warranted at this time.

• 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: 8297544
• MDR Text Key: 134753224
• Report Number: 1218950-2019-00928
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

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: 01/09/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2015
• 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