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

Model Number 867030

Device Problem Low Readings (2460)

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

Event Date 10/27/2023

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.E1: reporter institution phone number (b)(6).E1: reporter phone number (b)(6).

Event Description

The customer reported that the spo2 readings were incorrectly low, which resulted in oxygen being administered unnecessarily.The customer described this issue as a clinical near miss.The device was in use on patient at time of event, there was no adverse event reported.

Manufacturer Narrative

Further communication with the philips key market representative indicated the customer's issue were the disposable adult/pedi spo2 sensors.Philips requested for the return of the faulty disposable adult/pedi spo2 sensors to be evaluated.When the evaluation is completed a final report will be sent.

Manufacturer Narrative

This report is based on information provided by our philips failure analysis lab in cambridge, ma.Philips received a complaint on the disposable adult/pedi spo2 sensor lot number 0302695003 indicating the saturation sensors read low and incorrect a philips failure analysis investigator (fai) who received the device at the lab, visually inspected the device and found it be in unopened packaging.Functional testing was performed using an intellivue mp70 patient monitor, fluke prosim 8 vital sign simulator.Results showed the cable could produce a signal; however, the reading was low on two out of four samples from each box of five boxes returned, confirming the customer's allegation.Based from the information provided by the fai's evaluation, the customers allegation was confirmed.The spo2 sensors returned for analysis read low and incorrect.The customer had been provided replacement spo2 sensors to resolve the issue.No further investigation or action is warranted at this time.

• 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: deborah currlin ; hewlett-packard-str. 2,; b1-3/d6; boblingen 71034 ; GM 71034 ; 7031463203
• MDR Report Key: 18204655
• MDR Text Key: 328914026
• Report Number: 9610816-2023-00624
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: 00884838082588
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042306
• 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,Followup
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 867030
• Device Catalogue Number: 867030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2023
• Initial Date FDA Received: 11/24/2023
• Supplement Dates Manufacturer Received: 02/08/2024; Not provided
• Supplement Dates FDA Received: 03/08/2024; 05/29/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1