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

Model Number 865383

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 10/12/2023

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

It was reported the patient developed a burn at the nmt electrode site, possibly from the module temperature being set too high.

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.

• Brand Name: INTELLIVUE NMT MODULE
• Type of Device: 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 ; 7031463203
• MDR Report Key: 18074697
• MDR Text Key: 327421648
• Report Number: 9610816-2023-00564
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00884838029583
• UDI-Public: 00884838029583
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• 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?: Yes
• Device Operator: Health Professional
• Device Model Number: 865383
• Device Catalogue Number: 865383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/17/2023
• 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