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 06/02/2023

Event Type  malfunction  

Event Description

The customer reported the x3 shows incorrect higher spo2 values.The device was in use on a patient.There was no report of patient or user harm.

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.E1: reporting institution phone (b)(6).E1: reporter phone (b)(6).

Manufacturer Narrative

A philips response service engineer (rse) spoke to the customer.The device was sent to a philips authorized repair facility for evaluation.Diagnostic/functional testing were performed by a philips repair technician (brt) and the reported problem couldn't be replicated.The brt determined that the spo2 cable was possibly at fault.He advised the customer to change the cable and if the problem still exist, to send in for replacement of spo2 board.A good faith effort sent for the cable part number and description yield no results, as the brt informed "the customer has exposed of the old cable and replaced it themself." it was confirmed the customer resolved the issue by replacing the cable, and the device is now operating as intended.Results of functional testing indicates that the spo2 cable was possibly defective, but the reported problem could not be reproduced at the bench repair.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified at bench.Customer confirmed device working per specification after changing of spo2 cable.

• 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: 17124918
• MDR Text Key: 317340175
• Report Number: 9610816-2023-00278
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: 00884838082588
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K171801
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/14/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2020
• 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