MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE MX800 PATIENT MONITOR

Model Number 865240 (MX800)

Device Problem Device Alarm System (1012)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.Patient information requested not available at time of report.

Event Description

The customer reported that on (b)(6) 2019, a patient on ward 11-4 had a sudden drop in arterial pressure and was subsequently reanimated.Although this blood pressure drop was displayed on the monitor, the central had not alarmed.According to the customer, there were no alarms between 13:58 and 14:48.The patient had to be resuscitated.The resuscitation was successful.

Manufacturer Narrative

A philips field service engineer (fse) went onsite, and obtained alarm audit logs from the central station (pic ix).The alarm audit log was reviewed by a philips complaint investigator for the time reported.A blood pressure alarm was seen at 13:56:31; there was no indication in the logs that this alarm had been acknowledged.A philips response center engineer (rce) spoke with the customer, and the customer acknowledged that this was related to an alarm fatigue issue.The rce provided application support from a philips alarm fatigue specialist.There was no product malfunction.Based on the provided alarm audit logs, the system did provide a blood pressure alarm.

• Brand Name: INTELLIVUE MX800 PATIENT MONITOR
• Type of Device: INTELLIVUE MX800 PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8443216
• MDR Text Key: 139540454
• Report Number: 9610816-2019-00086
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838000261
• UDI-Public: (01)00884838000261
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

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: 865240 (MX800)
• Device Catalogue Number: 865039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 03/07/2019
• Supplement Dates FDA Received: 06/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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): Required Intervention