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

Model Number M3002A

Device Problem Unable to Obtain Readings (1516)

Patient Problems Arrhythmia (1721); Insufficient Information (4580)

Event Date 10/18/2023

Event Type  Injury  

Manufacturer Narrative

Reporting institution phone number: (b)(6).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.

Event Description

The customer reported that the intellivue multi measurement server x2 failed to measure ecg, resulting in the flatlining of the ecg waveform, on (b)(6) 2023 at 9:16 a.M.For a patient in the emergency department.The device was in use monitoring a patient at the time of the reported event.The patient passed away.

Manufacturer Narrative

During the investigation it was confirmed that the patient had a life-threatening arrhythmia event, but survived.The investigation is ongoing.

Event Description

The customer reported that the intellivue multi measurement server x2 failed to measure ecg, resulting in the flatlining of the ecg waveform, on (b)(6) 2023 at 9:16 a.M.For a patient in the emergency department.The patient had a life-threatening cardiac arrhythmia, but survived.

Manufacturer Narrative

Philips received a complaint on the intellivue multi measurement server x2, serial number unknown.On (b)(6) 2023, at 9:16 am in room 5 of the emergency department (b)(6), a patient was being monitored via x2 connected to an intellivue mx450 patient monitor with ecg and spo2.Parameters such as spo2 came through, however, the ecg did not and gave a flat line.The device was in use monitoring a patient at the time of the event.Fortunately, the patient did not die due to appropriate actions by the nurse (a defibrillator was connected to monitor the rhythm).When the defibrillator was connected, the patient turned out to have a life-threatening cardiac arrhythmia, which had not been detected by the x2.The patient was then transferred to room 2 for further monitoring.A philips clinical application specialist (cas) went onsite to collect additional information about the case.The cas reported that on october 11th, 2023, the mx450 monitors in the er were upgraded to software rev p.01.01.The x2 monitors had to be updated to rev m.04.05 software to be compatible with the newly upgraded mx450 monitors.Ever since the upgrade, there have been observations of failed ecg during monitoring, resulting in improper monitoring of the patient.The issues only occurred when the x2 was used in combination with the mx450.The cas retrieved the device strip logs from the customer to be evaluated by a philips product support engineer (pse).The philips pse evaluated the device strips and discovered the ecg strip report showed both the ecg and the respiration measurement were in inop condition, which meant no physiological alarm can be generated by the monitor.The alarm log documented inop conditions in the ecg parameter for both beds at the time of the event ((b)(6) 2023 @ ~09:00).Philips had investigated the ¿leads off¿ condition with the x2 hardware in 2016.Based on investigations at several customer sites, liquid can enter the ecg cable when the cables are off a patient and cleaned, or if they come in contact with fluids when they are connected to a patient.Liquid that enters the cables may cause a conductive connection between the lead and cable shield, referred to as "shunt impedance".The shunt impedances between conductors and shield inside the cable are caused by conductive liquids entering the electrode connectors (grabbers or snaps) or the connectors between lead sets and the trunk cable.In combination with the normal series resistance of the cable itself, a poor electrode-to-skin contact and/or poor electrodes with a relative high dc-offset voltage, the ecg signal might get lost resulting in a ¿leads off¿ inop.Based on these findings, ecg cables were improved at the grabber side to be less sensitive to fluid ingress.Also, an ecg firmware update had been introduced to be more tolerant in terms of shunt impedance caused by fluid ingress in the ecg cable.In conclusion, the ecg example previously mentioned above appears to be the result of a compromised ecg cables that were being used.Based on the information available and the device logs provided, the cause of the reported problem was due to the customer negligence to observe philips service bulletin sb86202447a.The service bulletin sb86202447a points to a firmware update e.01.22, to fix issues involving failed ecg during monitoring and counteracts happenings that may occur with ecg cables particularly fluid ingress.The x2 was operating on software m.04.05 and not the latest firmware version e.01.22.The pse advised the customer to check all other x2's in this department for the last fw version of the ecg measurement.Furthermore, the clinicians were instructed to carefully check their ecg accessories, esp.Trunk cable and lead set for obvious damage and moisture residuals at electric connectors before each use.After cleaning cables, only completely dried cables should be used on the patient; never immerse cables into cleaning/disinfection agent.Based on the information in the case and the device logs provided, the pse concluded this event was a result of a compromised ecg cable that was being used.Compromised cables would give poor skin contact and/or poor electrodes with a relatively high dc-offset voltage; as a result, producing the ecg signal to get lost, resulting in a ¿leads off¿ inop.If the customer had the latest version e.01.22 installed on the x2 monitor, there would not have been any issues with the ecg monitoring.The ecg firmware update had been introduced to be more tolerant in terms of shunt impedance caused by fluid ingress in the ecg cable.Furthermore, the pse's report concludes that these ecg failures were not related to the update of the x2's the customer had done.The pse referenced the service bulletin sb86202447a for further details regarding the ecg firmware update.The cas will be upgrading the ecg firmware on the x2¿s for the whole department.The device remains at the customer site.No further investigation or action is warranted.

• 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: 18009624
• MDR Text Key: 326553376
• Report Number: 9610816-2023-00545
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838000261
• UDI-Public: 00884838000261
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K150310
• 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

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/08/2023; 11/08/2023
• Supplement Dates FDA Received: 11/20/2023; 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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; Life Threatening