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

Model Number 865024

Device Problem Device Alarm System (1012)

Patient Problem Arrhythmia (1721)

Event Date 06/05/2023

Event Type  Death  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

A report was received that an 82-year-old gentleman admitted to the cardiac unit with nstemi was on a hard-wired mp 5 philips cardiac monitor which was connected to a central monitor at the nurse's desk.The patient was found unconscious by nursing staff.A code blue was activated and despite all resuscitation efforts patient could not be resuscitated.After the event staff noted critical arrythmia alarms did not alert staff as expected and is thought to be an equipment failure.Post event staff can see patient went into life threatening arrythmias however philips monitoring did not alert staff with a red 3-star alarm audible alert as expected.This record is associated with the event reported in mfr report number 1218950-2023-00446.

Manufacturer Narrative

The complaint was escalated for technical investigation including log file review, and the data for the timeframe associated with the patient and devices involved indicate that certain alarms and measurements were turned off by the user prior to the patient arrythmia.Based on the information available from the logs and data, the cause of the reported problem was deactivation of ecg/arrythmia alarms and respiration measurements as well as extended periods of ecg leads off, which led to delayed recognition of the patient condition.

Event Description

Additional information was received that the patient was admitted onto central.Ecg/arrhythmia alarms were turned off at 17:56, and the patient went into arrhythmia tachycardia 5:26 the next day and passed away.

• 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: hauke schik ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 17289020
• MDR Text Key: 318739048
• Report Number: 9610816-2023-00337
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000230
• UDI-Public: 00884838000230
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K150310
• 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

• Date FDA Received: 07/10/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/29/2012
• 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: 82 YR
• Patient Sex: Male