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

Model Number 865024

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2023

Event Type  Death  

Manufacturer Narrative

A follow-up report will be submitted upon completion of the investigation.Reporting address state: (b)(6).

Event Description

The customer reported that a baby died while being monitored by a philips bedside monitor (mp5).

Manufacturer Narrative

Additional information received indicating that the device was not a contributing factor in the patient's death.The nurse reportedly turned on the mp5 device and the display intermittently turned black.However, this issue occurred prior to placing the patient on the monitor; the monitor was not used.The customer confirmed the device did not cause or contribute to the patient's death, as the patient was not connected to the monitor during the reported patient event.This is no longer considered a reportable event.

• 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 ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16567786
• MDR Text Key: 311528628
• Report Number: 9610816-2023-00127
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000230
• UDI-Public: 00884838000230
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K150310
• 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?: No
• Device Operator: Health Professional
• Device Model Number: 865024
• Device Catalogue Number: 865024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/17/2023
• Supplement Dates Manufacturer Received: 03/09/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/09/2009
• 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): Death