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

Model Number 867036

Device Problem Incorrect Measurement (1383)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2024

Event Type  Injury  

Event Description

The customer reports that the patient's nibp was underestimated and they have administrated treatment to a baby who didn't need it.The device was used for patient monitoring at the time of the event.A neonatal patient received care he didn't need.

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.Reporting institution phone # (b)(6).

Manufacturer Narrative

Additional information was received which indicated the initial blood pressure measurement was low, so caregivers changed the blood pressure cuff site and fluid resuscitation was administered for the hypotension.It was determined when testing with old equipment the patient had normal blood pressure.Attempting to measure blood pressure with the old equipment showed a mean arterial pressure (map) of 41 compared to 29 with the new equipment.It was also indicated there was no impact on the patient's state after fluids were administered.Based on the additional information, there was no actual harm to the patient due to the reported complaint.No death, serious injury or adverse event was reported to have occurred as a result of this issue, nor is this issue likely to cause or contribute to such an event if it were to recur.This record has been deemed not reportable.The mean nbp value on the monitor is a measured value.The algorithm analyzes the oscillation envelope and computes the systolic, diastolic, and mean pressures.Some charting systems estimate the mean pressure by a rule of thumb.The product labeling recommends exercising caution when using the values of these charting systems.Discrepancies between a calculated mean and measured mean between two different systems will be identified by the user, allowing them to interpret the data and make appropriate clinical decisions for the patient.The information was reviewed by a philips product support engineer (pse) who identified the configuration may be incorrect, the customer claim was likely coming from wrong expectation due to measurements on neonates with wrong patient category and ¿auscultatory¿ as measurement category.A philips field service engineer (fse) went to the customer's site and confirmed the conflict between the monitor and central station pic ix, the adult profile from the pic ix was synchronized to the monitor which was in neonate profile.The profile was updated to neonate which resolved the customer's issue.

• Brand Name: INTELLIVUE MMX
• Type of Device: INTELLIVUE MMX
• 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: 18659500
• MDR Text Key: 334763339
• Report Number: 9610816-2024-00061
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838086760
• UDI-Public: 00884838086760
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K181831
• 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: 867036
• Device Catalogue Number: 867036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/07/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/08/2024
• 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): Other