MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP50

Model Number 862116

Device Problem No Audible Alarm (1019)

Patient Problem Asystole (4442)

Event Date 08/17/2023

Event Type  Injury  

Event Description

The customer reported that the intellivue mp50 patient monitor did not alarm for the neonatal patient in bed 8 when the heart rate dropped on (b)(6) 2023 at approximately 23:10.The device was in use monitoring a patient at the time of the reported event.The patient coded and clinical staff performed cpr for 15 seconds.The patient recovered.

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.

Manufacturer Narrative

Philips has received a complaint on the intellivue mp50 indicating "monitor did not alarm for the neonatal patient in bed 8 when the heart rate dropped on 16 august 2023 at 22:00.The patient coded and clinical staff performed cardiopulmonary resuscitation (cpr) for 15 seconds." the patient recovered.A philips field service engineer (fse), clinical application specialist (cas) and a national support specialist (nss) went onsite, looked into the clinical audit log in the philips system and reviewed the alarms for the monitor.They were able to see asystole alarms for the time frame in question and confirmed that the monitor did in fact alarm.Multiple yellow and red alarms were generated between 22:10 and 24:00 on 16-august-2023 for bed nicu 8.A red vtach alarm was generated at 22:27:59, followed by an asystole alarm at 23:12:49 which was acknowledged at the bedside monitor.In addition, several red alarms were generated and were paused during the time frame of 22:00 until 00:00 on 16-august-2023, with the pause lasting three minutes.Furthermore, the fse and biomed tested the monitor using a patient simulator and confirmed that the monitor did alarm as expected.Based on the information available, pse log review and tests conducted, it has been determined that the intellivue mp50 patient monitor was functioning/alarming per specification.Alarms were acknowledged by the staff.The intellivue mp50 patient monitor did not cause or contribute to the reported event.The cause of the reported problem was an user error.The reported problem was not confirmed.The investigation concludes that no further action is required.The device remains at the customer site.

• Brand Name: INTELLIVUE MP50
• Type of Device: INTELLIVUE MP50
• 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: 17681625
• MDR Text Key: 322604752
• Report Number: 9610816-2023-00444
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151681
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 862116
• Device Catalogue Number: 862116
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2009
• 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): Required Intervention