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

Model Number	867030
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported in the intensive care units and the operating room using the recently installed x3 monitor, the non-invasive diastolic blood pressure measurement is 15-20mmhg lower than the invasive pressure measurement on pediatric patients, which has resulted in unnecessary treatment such as inotropic medications and fluid boluses.This alleged issue was also present in adult patients.The patients are monitored for pulse, spo2, and blood pressure continuously.Simulations on both old equipment and new equipment did not reveal any difference; however, on real patients, the difference is evident to the customer.Based on the information that patients have received unnecessary vasoactive medications, which would be considered a medication error due to the alleged malfunction, this event would be considered a serious injury at this time.
Additional Manufacturer Narrative
Philips received a complaint on the intellivue x3 indicating that the in the intensive care units and the operating room using the recently installed x3 monitor, the non-invasive diastolic blood pressure measurement is 15-20mmhg lower than the invasive pressure measurement on pediatric patients, which has resulted in unnecessary treatment such as inotropic medications and fluid boluses.This alleged issue was also present in adult patients.The patients are monitored for pulse, spo2, and blood pressure continuously.Simulations on both old equipment and new equipment did not reveal any difference; however, on real patients, the difference is evident to the customer.Based on the information that patients have received unnecessary vasoactive medications, which would be considered a medication error due to the alleged malfunction, this event would be considered a serious injury at this time.Additional information was provided which indicated the patient had no symptoms of hypotension (tachycardia, signs of poor peripheral circulation, etc).It was also indicated this issue occurred with multiple patients but there were no specific details provided by the customer.In general, there were several cases of extremely low diastolic blood pressure, both in neonates and in older children and teenagers with non-invasive blood pressure.When possible, these low values were compared with invasive blood pressures, which revealed significant differences in many patients.In some cases, patients were treated with fluid boluses and/or vasoactive medications.In some cases, arterial lines were placed in infants to monitor pressure, though that was not the standard routine during all procedures.There were no known adverse reactions to those interventions.The was no further specific event information provided for the multiple events.Clinical audit logs, configuration files and disposition of the equipment were all requested but were not provided by the customer.The product information was also not provided, and testing of the device was unable to be performed.Research and development (r&d) visited the site to perform trouble shooting and speak to the customer.It was identified that the hospital had changed the reference mode from auscultatory to invasive based on a customer letter released 3 years prior.After that change, the diastolic values were very low.It was confirmed that the hospital was using all original philips tubing and cuffs; however, the application of the cuffs was not able to be confirmed.They were unable to confirm if the correct patient category is used in all cases since the incorrect category was observed to be used in some circumstances.R&d recommended the customer keep the reference as auscultatory for pediatric cases.Based on the information available and the testing conducted, the cause of the reported problem was the use of the invasive reference standard mode over the auscultatory reference for pediatric patients.The reported problem was confirmed.The device was operational after repairs were completed.

• Brand Name: INTELLIVUE X3
• Common Device Name: 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 ; 70314632031
• MDR Report Key: 19659167
• Report Number: 9610816-2024-00396
• Device Sequence Number: 6540604
• Product Code: MHX
• UDI-Device Identifier: 00884838082595
• UDI-Public: (01)00884838082595
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K171801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: 867030
• Device Catalogue Number: 867030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown