MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP30

Model Number 862135

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2021

Event Type  Death  

Event Description

It was reported that the intellivue mp30 patient monitor was used on a patient that passed away on (b)(6) 2021.No further information was provided by the customer.The device was in use monitoring a patient at the time of the reported event.The death of a patient was reported.No additional details regarding the patient, such as gender, age, height, and weight, were reported.

Manufacturer Narrative

A philips field service engineer (fse) went to the customer site and obtained the clinical audit log from the central station for the event date.Despite multiple good faith efforts to obtain additional information regarding the reported death and the allegation against the mp30 monitor involved in the event, no further details were made available by the customer.As the exact time, bed label, and allegation against the monitor were not provided, an analysis of the provided clinical audit log was not possible.The cause for the reported event could not be determined and it remains unknown how this issue was resolved.Multiple good faith efforts were made to obtain additional information regarding the reported event and how this issue was resolved for the customer, but have been unsuccessful.An investigation of the reported event was not possible and the resolution for the reported problem is unknown.No further investigation or action is warranted at this time.

• Brand Name: INTELLIVUE MP30
• Type of Device: INTELLIVUE MP30
• 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: 13939810
• MDR Text Key: 288118893
• Report Number: 9610816-2022-00159
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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: 862135
• Device Catalogue Number: 862135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2021
• Initial Date FDA Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: No
• 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