MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP70

Model Number 862451

Device Problem Low Audible Alarm (1016)

Patient Problem Insufficient Information (4580)

Event Date 06/24/2022

Event Type  Death  

Manufacturer Narrative

Reporting institution phone #: (b)(6).Reporter phone #: (b)(6).A follow-up report will be submitted upon completion of the investigation.

Event Description

It was reported the alarm limits were reduced but weren¿t turned back up again and as a result, when the patient deteriorated the clinical staff were not audibly alerted due to the reduced volume.The patient passed away.

Manufacturer Narrative

Philips field service engineer (fse) went to the customer site.The fse retrieved the device logs which were sent to a philips clinical application specialist (cas) for review.The configuration report of the device indicates the alarms settings are defaulted to alarm volume of 6 and are able to be turned down to a volume of 2.The customer is using the traditional alarm sounds, and the pause alarm time is set for 2 minutes.The cas also verified from the configuration report the adult patient category is saved to the pedi profile.The pedi profile is using the same alarm limits for the pedi profile for the hr/ecg measurement.The monitor is in cardiotach mode, indicating the device would only generate ecg alarms for asystole, v-fib/tach, extreme high, extreme low, hr high and hr low.The spo2 alarm limits configuration is different on the screen shot vs the monitor.The spo2 configuration is 100% high / 92% low, but the screen shot shows the alarm limits on the monitor are 100% high / 90% low (this matches the adult measurement settings).The non-invasive blood pressure (nibp) limits in the configuration file for the pedi profile is sys high - 140 and sys low - 80.The screen shot shows the limits of sys high - 160 and sys low - 90 (this matches the adult measurement settings).The art limits in the configuration file for the pedi profile is sys high - 140 and sys low - 80.The alarms are off for the art.The rr limits in the configuration file for the pedi profile is high - 35 and low - 10.The screen shot shows the limits of high - 30 and low - 8 (this matches the adult measurement settings).A review of the device logs and monitor configuration determined the device was working as intended and configured with no failures found.The device was being used to monitor a pedi patient, with the profile configuration set to adult.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE MP70
• Type of Device: INTELLIVUE MP70
• 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 st; cambridge, MA 02141 ; 6172455900
• MDR Report Key: 14430333
• MDR Text Key: 291954977
• Report Number: 9610816-2022-00273
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• 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: 862451
• Device Catalogue Number: 862451
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/18/2022
• Supplement Dates Manufacturer Received: 07/06/2022
• Supplement Dates FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2007
• 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: 66 DA
• Patient Sex: Female
• Patient Weight: 3 KG