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

Model Number	865040
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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 ; 70314632031
• MDR Report Key: 18518912
• Report Number: 9610816-2024-00018
• Device Sequence Number: 6750817
• Product Code: DSI
• UDI-Device Identifier: 00884838000278
• UDI-Public: 00884838000278
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K150310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 865040
• Device Catalogue Number: 865040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/29/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown