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

Model Number 867030

Device Problem No Device Output (1435)

Patient Problem Insufficient Information (4580)

Event Date 12/28/2023

Event Type  Injury  

Event Description

It was reported there was a saturation problem in which the spo2 disappeared on the monitor; therefore, spo2 monitoring was unavailable the there was a delay in extubation.The monitor was power cycled, and cables were changed with no resolution.The device was in use on a patient.There was a report of patient or user harm.

Manufacturer Narrative

Based on the information available and the testing conducted, the cause of the reported problem was the masimo spo2 adapter cable.The reported problem was confirmed.The adapter cables were picked up at the customer site by a masimo representative for analysis.Masimo stated in their pre-liminary investigation result that several of the analyzed adapter cables show a chemical contamination of the connectors (sensor side & monitor side).Masimo advised that it could be caused by inappropriate decontamination of the adapter cables.Masimo will provide new adapter cables to the customer and teach them to clean the adapter cables correctly.If additional information is received the complaint file will be reopened.Reporter phone number: (b)(6).Reporting institution phone number: (b)(6).

• 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: 18863283
• MDR Text Key: 337181571
• Report Number: 9610816-2024-00125
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838082588
• UDI-Public: 00884838082588
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K171801
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 02/10/2024
• Initial Date FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2021
• 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): Other
• Patient Age: 42 YR
• Patient Sex: Male