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

Model Number 865024

Device Problem Incorrect Measurement (1383)

Patient Problem Cyanosis (1798)

Event Date 12/01/2023

Event Type  Injury  

Event Description

The customer reported that a child was connected to a patient monitor at 8 a.M.On december 1, 2023 but during patient inspection, the child was found to be cyanotic despite the monitor showing spo2 90%.After swapping to a new monitor, the child¿s spo2 actually showed 67% and the patient was subsequently treated with positive pressure ventilation and oxygen.Their spo2 rebounded to 95% and signs of cyanosis resolved after 1 minute of oxygen therapy.No other clinical information or medical intervention was reported.

Manufacturer Narrative

The equipment was tested, revealing a faulty spo2 sensor, which was replaced by the hospital to resolve the issue.The faulty spo2 sensor may have caused or contributed to the reported cyanosis, meeting the criteria for serious injury.The cause of the reported problem was the spo2 probe.The reported problem was confirmed.The device was operational after replacing the spo2 probe.E1 reporting address state: (b)(6).

• 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 ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18537864
• MDR Text Key: 333167739
• Report Number: 9610816-2024-00028
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000230
• UDI-Public: 00884838000230
• 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: 01/18/2024
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/26/2012
• 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