MAUDE Adverse Event Report: PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH NMT CABLE; STIMULATOR, NERVE, PERIPHERAL, ELECTRIC

Model Number	INTELLIVUE NMT PATIENT CABLE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	11/11/2025
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 a patient had suffered from burns after being monitored by neuromuscular transmission (nmt) equipment.No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.
Additional Manufacturer Narrative
Additional information was received.The additional information was reviewed.It was reported that when removing the pad after use during the operation the issue was noticed.It is noted that this originated from the red lead.The burn was described as severe redness and a small burn.The burn was treated with ointment, observed for a couple of days, no blisters, resolved spontaneously.The ointment the patient was treated with is considered first aid over the counter and does not meet the criteria for medical intervention.Per the response, no permanent damage, no further action taken.The new information provided clarifies the injury.This burn meets the criteria for a non-serious minor injury.This is no longer considered a reportable complaint with philips.

• Brand Name: NMT CABLE
• Common Device Name: STIMULATOR, NERVE, PERIPHERAL, ELECTRIC
• 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: 23568580
• Report Number: 9610816-2025-001072
• Device Sequence Number: 9885524
• Product Code: KOI
• UDI-Device Identifier: 00884838073715
• UDI-Public: (01)00884838073715
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: INTELLIVUE NMT PATIENT CABLE
• Device Catalogue Number: 989803174581
• Device Lot Number: 0123
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2023
• 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: Required Intervention
• Patient Sex: Unknown