MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP5

Model Number 865024

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

Patient Problem Insufficient Information (4580)

Event Date 08/06/2022

Event Type  Death  

Event Description

It was reported there was a patient incident that occurred on (b)(6) 2022.The customer has requested the device configuration files and logs be reviewed.The device was in use at time event, and it was reported a patient died.

Manufacturer Narrative

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

Event Description

It was reported there was a patient incident that occurred on (b)(6), 2022.The customer has requested the device configuration files and logs be reviewed.The device was in use at time event, and it was reported a patient died.Device logs were provided to a philips clinical specialist (cs) for review.The cs reviewed the logs and noted that the philips mp5 patient monitor was associated with the classic philips intellivue information center (piic) on (b)(6) 2022 at 20:14:5, and remained connected until a new association on (b)(6) 2022 at 13:13:07 with an abort message was sent from the piic central.The cs indicated that this could be due to the monitor being turned off and the association with the piic was not established.The classic piic was showing the association of 4 waves ¿ ecg lead ii, v, and avr, and pleth.9 parameters were displayed.An asystole alarm was sounded at 8:12:03.This alarm played until it was silenced at 08:22.00 from the piic (piic did not log bedside interactions).At 10:50:22, the alarms were suspended and then unsuspended at 10:51.22.Based on the configuration file of the mp5 monitor, alarms were audibly latched for red alarms and visually latched for red and yellow alarms.From the logs, the asystole alarm played for 10 minutes before it was silenced at the piic.After this time, there would have been a short reminder of the red alarm every three minutes according to the configuration file (alarm reminder set to on and reminder time was three minutes.The cs could also tell the monitor entered and exited standby at 09:54:06, 10:50:19, and 12:28:00.The patient data was discharged and saved at 12:27:55 on (b)(6).This information was provided to the customer as requested.

• Brand Name: INTELLIVUE MP5
• Type of Device: INTELLIVUE MP5
• Manufacturer (Section D): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer (Section G): PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034
• Manufacturer Contact: jeanne ahearn ; 222 jacobs st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 15294339
• MDR Text Key: 298601470
• Report Number: 9610816-2022-00457
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000230
• UDI-Public: 00884838000230
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• 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: 865024
• Device Catalogue Number: 865024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2022
• Initial Date FDA Received: 08/25/2022
• Supplement Dates Manufacturer Received: 08/09/2022
• Supplement Dates FDA Received: 12/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2012
• 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
• Patient Age: 47 YR
• Patient Sex: Male