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

Model Number 722467

Device Problems Unable to Obtain Readings (1516); Insufficient Information (3190)

Patient Problem Ventricular Fibrillation (2130)

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported that the hemodynamics on (b)(6) 2023 failed due to a patient incident.No ecg evaluation - ventricular fibrillation.The system was in clinical use.Patient harm was reported as the patient was resuscitated twice.

Event Description

Philips received a complaint on the philips hemo system with intellivue x3 sn (b)(6) indicating there was no ecg evaluation possible due to artifacts.The patient had ventricular fibrillations and had to be resuscitated twice.Ventricular fibrillation occurred with the need for resuscitation which was not recognized by the ecg due to the poor quality of the ecg derivation of the system.Defibrillation was then only initiated when the blood pressure dropped.After 1st defibrillation on the ecg of the system, there was still no adequate rhythm analysis possible due to artifacts, which caused a delay in defibrillation.Only through the defibrillator lead was an ecg evaluation possible.Therefore, to recognize an ecg rhythm a 2nd shock was necessary.

Manufacturer Narrative

A philips remote service engineer (rse) remotely interviewed the customer who was onsite.Later, the rse dispatched a field service engineer (fse) onsite.It was confirmed that philips device did not cause or contribute to the reported ventricular fibrillations.At the time of the event the patient was undergoing an emergency cardiac catheterization for diagnostic coronary angiography.The event occurred while probing the right coronary artery (rca).The customer was provided replacement ecg electrodes to resolve the issue.Based on the information available, the cause of the reported problem was confirmed to be the ecg electrodes.Without the material being returned, we are not able to perform an evaluation to determine the cause of the reported incident.A clinical harm review was performed as there was a report of patient harm.It has been reported "no ecg evaluation.Repeated problems with the ecg display.No ecg evaluation was possible due to artifacts, a defi was connected to the patient, the patient had ventricular fibrillations and had to resuscitate 2 x." no other clinical details were provided.It is unclear if the reported ventricular fibrillations are reported to have been related to the philips device, or, if the patient experienced this condition while undergoing a unknown procedure.This file is being classified as a serious injury.After the ecg electrodes were replaced, the device was returned to functional use with no further issues identified.Without the material being returned, we are not able to perform an evaluation to determine the cause of the reported incident.The device remains at the customer site.No further investigation or action is warranted at this time.

• Brand Name: PHILIPS HEMO SYSTEM WITH INTELLIVUE X3
• Type of Device: PHILIPS HEMO SYSTEM WITH 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: 16975779
• MDR Text Key: 315739654
• Report Number: 3003768277-2023-02971
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,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?: No
• Device Operator: Health Professional
• Device Model Number: 722467
• Device Catalogue Number: 722467
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 75 KG