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

Model Number M3002A

Device Problem Device Alarm System (1012)

Patient Problem Hypoxia (1918)

Event Date 08/18/2023

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.H3 other text : the customer rejected repair quote.

Event Description

It was reported the patient desaturated into the 30s and 40s and the device failed to generate an alarm.The biomed has been unable to confirm the alarms are failing as they are unable to recreate the alarm issue.An oxygen desaturation to 30% or 40% represents a change in the patient's clinical condition which can be considered life-threatening and typically requires intervention to preclude permanent impairment; therefore, this event meets criteria for a serious injury based on the information received.Details of the event are incomplete and additional information has been requested.

Manufacturer Narrative

A philips remote service engineer (rse) the customer requested the central station and monitor logs be pulled.Philips provide a quote for onsite service; however, the customer cancelled the onsite service.Requests were made for additional information and no information was received.The root cause is unable to be determined with the information available; however, the suspected cause is possible user error as issue cannot be recreated.

• Brand Name: INTELLIVUE MULTI MEASUREMENT SERVER X2
• Type of Device: PATIENT MONITOR
• 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: 17738160
• MDR Text Key: 323304140
• Report Number: 9610816-2023-00460
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3002A
• Device Catalogue Number: M3002A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2023
• Initial Date FDA Received: 09/13/2023
• Supplement Dates Manufacturer Received: 10/07/2023
• Supplement Dates FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2017
• 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): Life Threatening; Required Intervention