MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE MULTI MEASUREMENT SERVER X2

Model Number M3002A

Device Problem Incorrect Measurement (1383)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2023

Event Type  Death  

Event Description

It was reported during monitoring of a patient with gsw x3 to the head the arterial line measurement did not display on the x2 monitor.The cause of the issue was found to be the x2 did not register the art/temp measurement board, so it was recommended to replace the board.The device was in use at time of the event and the patient died.

Manufacturer Narrative

The field service engineer (fse) went onsite and confirmed the problem that arterial blood pressure (abp) should have displayed.The fse determined that the cause of the issue was that the x2 monitor did not register the ecg/temperature measurement board.The customer was advised to replace ecg/temp measurement board and ensure it is detected by the x2 monitor.The customer was advised to replace the parameter board.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

The device was sent to philips bench repair.A philips bench repair technician (brt) evaluated the device and confirmed the issue; pressure line will not operate due to a faulty parameter board and main board.The cause of the reported problem was the parameter board and main board.The reported problem was confirmed.The device was operational after replacing the parameter board and main board.The device was returned to the customer.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Type of Device: INTELLIVUE MULTI MEASUREMENT SERVER X2
• 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: 18012923
• MDR Text Key: 326630195
• Report Number: 9610816-2023-00544
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000261
• UDI-Public: 00884838000261
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,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

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M3002A
• Device Catalogue Number: M3002A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2011
• 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): Death