MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP20

Model Number 862134

Device Problem Device Alarm System (1012)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

This is a supplemental report to 1218950-2021-10518.This report has correct registration and product information.The customer biomed electronically sent a philips remote service engineer (rse) the device logs for review.Upon review of the logs, the rse identified multiple alarms being generated for the bp when outside of range.Further review of the logs, showed a sensor was disconnected at 09:53am, which generated a red alarm.The rse identified the extreme alarms are disabled by default on the bp for all profiles (adults, pediatrics, neonatal), resulting in no red alarm being generated.The rse confirmed the monitor was working as intended and configured.There was no product malfunction identified.The rse shared the findings with the biomed and remotely provided device configuration assistance to enable the extreme limits.A review of the device logs indicated the extreme alarms limits are disabled by default, which was resolved by the rse instructing the biomed on configuring the extreme limits on the device to resolve the red alarm not sounding issue as reported.

Event Description

The customer reported their intellivue mp20 patient monitor triggered a yellow blood pressure (bp) alarm, which should have sounded as a red alarm on (b)(6) 2021 at 07:30am.The device was reported to be in use on a patient, the patient required intubation.

• Brand Name: INTELLIVUE MP20
• Type of Device: INTELLIVUE MP20
• 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: derek sammarco ; 222 jacobs street; cambridge, MA 02141
• MDR Report Key: 12231092
• MDR Text Key: 264695247
• Report Number: 9610816-2021-10257
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K122439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial

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: 862134
• Device Catalogue Number: 862134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/07/2021
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2006
• 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): Hospitalization