MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MP2

Model Number 865040

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

The customer indicated the hospital's technical engineer (te) evaluated the unit and found the blood oxygen probes to be the root cause of the issue.The te provided the customer with replacement blood oxygen probes to resolve the issue.Philips requested for the faulty blood oxygen probes to be returned for evaluation; however, they were unavailable.No further investigation or action is warranted at this time.Reporting address line: (b)(6).Reporter phone: (b)(6).Reporting institution phone (b)(6).

Event Description

Philips received a complaint on the intellivue mp2 sn (b)(6) indicating a situation of a child hospitalized due to bronchial pneumonia.On (b)(6)2023, the blood oxygen saturation of the child dropped to 88%.At the moment of the child's coughing and holding, the monitor did not alarm.However, a nurse in charge at the time heard the child and immediately rushed to the bedside to check on the patient.After oxygen inhalation, atomization and back patting, the patient's condition was relieved, and the ecg monitor was replaced.The device was in use on patient at time of event, there was no adverse event reported.It was mentioned there was a possible delay in rescue.

• Brand Name: INTELLIVUE MP2
• Type of Device: INTELLIVUE MP2
• 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: 18518912
• MDR Text Key: 332938603
• Report Number: 9610816-2024-00018
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000278
• UDI-Public: 00884838000278
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 865040
• Device Catalogue Number: 865040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2017
• 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