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

Model Number 862451

Device Problem No Audible Alarm (1019)

Patient Problem Insufficient Information (4580)

Event Date 05/06/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported: a vital alarm did not ring.The device was in clinical use and there was an adverse event reported.

Manufacturer Narrative

H10: a philips field service engineer (fse) went to the customer site.The engineer tested the device in demo mode and with a simulator and found that the curves and numerical values were correctly displayed on the screen and that the visual and audible alarm indicators were correctly reported, especially for spo2 alarms.The fse provided audit logs, however after the logs were reviewed it was determined that the logs were for the incorrect bedside label and the incorrect day.The fse provided a screenshot of the correct logs.Review of the screenshot determined that there is not enough information to determine whether the device did not alarm.The configuration logs were requested but not provided.The screenshot shows the yellow alarm was generated at spo2 84% and again at 80%.The low limit was set to 85%.The config files would help determine what the desat limit was set to and how much time the patient has to be at that level for the alarm to occur.Spo2 alarms have a delay time for high and low and a separate delay time for desat.That is set in configuration.The default is 10 sec for high and low and 20 sec for desat.This complaint is about an spo2 of 78 not sounding.If the patient had a 78 spo2 and it didn¿t alarm either the desaturation limit was lower than 78 or the patient did not stay at 78 for greater than the desaturation alarm limit time.The low spo2 alarm was silenced at the pic 2 min later followed by an extreme bradycardia (xbrady 45<50) at 11:55 which was also silenced at the pic.Without the config, philips cannot speak to the desat limit setting (which can be changed per patient) or the desat alarm delay setting which can¿t be changed per patient.The cause of the event is unknown.The device was removed from service.

Event Description

It was reported: a vital alarm did not ring.The device was in use at time of event and a patient death was reported.

• 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen, MA 71034 ; GM 71034 ; 6172455900
• MDR Report Key: 14518927
• MDR Text Key: 292785414
• Report Number: 9610816-2022-00299
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• 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: 862451
• Device Catalogue Number: 862451
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 02/14/2023
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/06/2007
• 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