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

Model Number 866389

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 12/13/2019

Event Type  Death  

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site and pulled the system log.There was no technical or clinical problem found for the philips equipment.The fse was told by the biomed that nurses at the central station (pic ix) made the alarm volume low and didn¿t hear alarm for that patient: there was no product malfunction; this was a user issue, as the nurses had turned the volume of the alarm too low to hear.The customer biomed noted that after this incident, they are required to have central station (pic ix) alarms on no lower than 7 all the times.The device remains in use at the customer site.No subsequent calls have been logged for this device/issue.No further investigation or action is warranted at this time.

Event Description

The customer biomedical engineer (biomed) and it person, the clinical user claims that on (b)(6) 2019 at 11:10 am,.The patient arterial pressure (art label) decreased to 90 mm hg then 70 mm hg then to zero pressure; the central station (piic ix) sector displays a visual yellow pressure alarm banner but no audible alarms.The patient died.

• 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: 9492865
• MDR Text Key: 171955223
• Report Number: 1218950-2019-09567
• 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
• Report Date: 12/14/2019

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?: No
• 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: 12/14/2019
• Initial Date FDA Received: 12/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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 Age: 83 YR