MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH INTELLIVUE NMT MODULE

Model Number	865383
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2024
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 the measurement was unreliable and the anesthesiologist administered medication to reverse paralytic agents.No other clinical information or medical intervention was reported; therefore, good faith efforts are ongoing.
Additional Manufacturer Narrative
This report is based on information provided by philips clinical application specialist and has been investigated by the philips complaint handling team.Philips received a complaint on the intellivue nmt module indicating that the measurement was unreliable, and the anesthesiologist administered medication to reverse paralytic agents.There was no actual harm reported but the customer noted the drug sugammedexin can affect birth control pills.The customer indicated in some cases too much medication was used and other cases involved waking patients up from surgery.It was also noted the customer believes the calibration procedure was too complicated and takes too long to perform.Measurements while waking up the patient display very high and then the user cannot determine whether values are high or low.The philips clinical application specialist has been onsite observing in the operating room to help troubleshoot.A clinical application specialist also observed users calibrating the nmt function.This revealed mixed results in that some calibrations did not work correctly, several were due to incorrect placement, light sedation, patient movement, etc.There was nothing conclusive as to the cause of the reported issue.Reversal of the paralytic agent due to an alleged malfunction will continue to be considered a harm.The complaint is still under investigation.A final report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
Philips received a complaint on the intellivue nmt module indicating that the measurement was unreliable, and the anesthesiologist administered medication to reverse paralytic agents.There was no actual harm reported but the customer noted the drug sugammedexin can affect birth control pills.The customer indicated in some cases too much medication was used and other cases involved waking patients up from surgery.It was also noted the customer believes the calibration procedure was too complicated and takes too long to perform.Measurements while waking up the patient display very high and then the user cannot determine whether values are high or low.The philips clinical application specialist has been onsite observing in the operating room to help troubleshoot.A clinical application specialist also observed users calibrating the nmt function.This revealed mixed results in that some calibrations did not work correctly, several were due to incorrect placement, light sedation, patient movement, etc.There was nothing conclusive as to the cause of the reported issue.Calibration needs to be completed prior to the administration of neuromuscular blocking agents.It is not mandatory to complete the calibration procedure, but philips recommends calibration to determine and apply the individual supramaximal stimulation current for a patient.Calibration checks and ensures the proper working of the nmt measurement system.If there is no time for a calibration, the nmt, measurement can be used for qualitative assessment of muscle relaxation.Based on the information available, the reported problem is related to application and setup of the device.The reported problem was not confirmed.A clinical harm review was performed, and the event was reviewed by a clinical expert.This event is assessed as possibly related to a product problem; however, there was nothing conclusive found during an onsite visit as to the cause of the reported issue.Reversal of the paralytic agent due to an alleged malfunction will be considered a harm; however, it remains unknown whether this issue was the result of a malfunction, use error, or some other factor in use of the device.No further action is required.Results of the investigation were inconclusive, and it is unclear if the was related to an unidentified product malfunction, use error or another unidentified factor.In order to resolve the issue, multiple training sessions and a workshop for nurses and doctors were provided to in order to ensure correct setup.

• Brand Name: INTELLIVUE NMT MODULE
• Common Device Name: INTELLIVUE NMT MODULE
• 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: 20560247
• Report Number: 9610816-2024-00758
• Device Sequence Number: 19605063
• Product Code: DSI
• UDI-Device Identifier: 00884838029583
• UDI-Public: (01)00884838029583
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K150310
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2025

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: 865383
• Device Catalogue Number: 865383
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 12/05/2024; 01/09/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/30/2024; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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: Other
• Patient Sex: Unknown