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

Model Number	865383
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported the patient developed a burn at the nmt electrode site, possibly from the module temperature being set too high.
Additional Manufacturer Narrative
The clinical application specialist (cas) spoke to the customer, and the customer stated that the site was rotated, and electrodes were changed.A philips field service engineer (fse) was dispatched to perform testing on the device.The fse visited the site two times, and after talking to clinical engineers and the customers biomedical management, the fse was told that at this point, there is no action needed from the philips team regarding patient injury investigation.The customer site advised that they are doing their own investigation and will reach out to the philips team if needed.H3 other text : customer refuses investigation of device.
Additional Manufacturer Narrative
D4: data correction to device identifier.

• 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: 18074697
• Report Number: 9610816-2023-00564
• Device Sequence Number: 7594414
• Product Code: DSI
• UDI-Device Identifier: 00884838029583
• UDI-Public: (01)00884838029583(21)DE75326170
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

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: 865383
• Device Catalogue Number: 865383
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 12/08/2023; 07/08/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/19/2023; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2023
• 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