MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2

Model Number 865039

Device Problem Defective Alarm (1014)

Patient Problem Bradycardia (1751)

Event Date 07/21/2021

Event Type  Death  

Event Description

The customer reported a patient incident because the system gave no alarm.The device was used for patient monitoring at the time of the alleged malfunction.The customer stated the patient died.

Manufacturer Narrative

The customer reported there was no bradycardy/asystoly alarm on bed 16.2 on (b)(6) 2021, 15:10 pm.In the alarm configuration, a deviation from the factory default is set so that red and yellow alarms end automatically when the cause of the alarm ends.This means that as soon as the defined alarm limits are no longer violated, the alarm and its tone can no longer be seen or heard on the monitor and control center.This setting was already set before the last configuration adjustment.A field service engineer (fse) went on-site to collect the relevant alarm logs, audit files, configuration logs and alarm review of the monitor and pic ix for the time of the reported event.The ecg stripes were provided by the customer.The fse reviewed, tested and found all devices and systems to be working as intended.On the basis of the available data, no apparent malfunction of the systems can be seen, they worked according to their configuration.Different red alarms were reported between 2:59 p.M.And 3:14 p.M., which ended automatically after the cause of the alarm had ended.A first acknowledgment of alarms can be seen at 3:14 p.M.On the monitor of the bed 16.2 itself.The report of a lack of bradycardia or asystole cannot be reproduced in the available data.The responsible product support engineer reviewed the collected files and data as well and stated the following: the device sounded the alarm in the specified period, an asystole was reported at 3:07 pm.I do not consider the expectation of a brady or asystole alarm at 3:10 p.M.To be plausible based on the ecg signal and the hr values in the trend data.The fse and pse confirmed both that the device alarmed correctly to the time of the reported event and there is no malfunction.All devices were tested and working as expected, are fully functional and did not cause or contribute to the patient death.

Event Description

The customer reported on (b)(6) 2021 that the system gave no alarm.The device was used for patient monitoring at the time of the alleged malfunction.A patient died.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Type of Device: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• MDR Report Key: 12225751
• MDR Text Key: 263419571
• Report Number: 9610816-2021-10255
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000261
• UDI-Public: 00884838000261
• Combination Product (y/n): N
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup

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: 865039
• Device Catalogue Number: 865039
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/22/2021
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 07/26/2021
• Supplement Dates Manufacturer Received: 07/22/2021
• Supplement Dates FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR