MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE X3

Model Number 867030

Device Problem High Readings (2459)

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

Event Date 04/09/2024

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.Reporting institution phone number: (b)(6).Reporter phone number: (b)(6).

Event Description

Customer reported that high values are displayed, the patient is already slightly bluish and then the spo2 abruptly goes down to 68.

Manufacturer Narrative

This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the intellivue x3 indicating that "high values are displayed, patient is already slightly bluish and then abruptly goes down to 68." it is not known that the device was in use at the time of the event.A philips remote service engineer (rse) spoke with the customer and the customer alleged that spo2 values are sometimes delayed and sometimes did not correspond to the status of the patient.The rse informed the customer that in order to find the cause of the problems with the spo2 alarm, philips would like to check some points like compatibility of the sensor and extension cable, configuration of the alarm delay and the aeration, and quality of the spo2 discharge when the problem occurred.The rse also advised the customer to check whether the perfusion value was over 1.0 and the signal quality display was at least in the middle range.The rse did not receive any response from customer's end so no work was performed by philips.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.The engineer provided their analysis findings however we are unable to confirm the final disposition of the device because the customer did not respond to requests for additional information.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: INTELLIVUE X3
• Type of Device: INTELLIVUE X3
• 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: 19145447
• MDR Text Key: 340739861
• Report Number: 9610816-2024-00212
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: 00884838082588
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K171801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• 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
• Device Operator: Health Professional
• Device Model Number: 867030
• Device Catalogue Number: 867030
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• 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