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

Model Number	989803174581
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the patient had a burn on his thumb, which, when checked, revealed that the coating of the nmt cable had been broken, exposing the conductor.The burn occurred at the electrodes.
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.
Additional Manufacturer Narrative
Philips received a complaint on the intellivue nmt patient cable indicating that cable had ruptured.The patient sustained minor burns that were treated with ointment from the medical staff.The investigation was conducted by the product support engineer at the hpm r&d in germany.Visual inspection found that the cable had been ruptured leading to the exposure of the inside shielding and wires.Results of functional testing indicate that the cable was damaged during storage of the unit at the medical facility over a period of time.Based on the information available and the testing conducted, the cause of the reported problem was broken cable.The reported problem was confirmed.Clinical assessment was performed by a pms clinical expert based on the information currently available in the complaint record.Due to insufficient information, it cannot be determined whether the event meets criteria for serious injury.The returned device has been discarded per local procedures.

• Brand Name: INTELLIVUE NMT PATIENT CABLE
• Common Device Name: INTELLIVUE NMT PATIENT CABLE
• 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: 18517462
• Report Number: 1218950-2024-00031
• Device Sequence Number: 17811520
• Product Code: MHX
• UDI-Device Identifier: 00884838073715
• UDI-Public: 00884838073715
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122439
• 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

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: 989803174581
• Device Catalogue Number: 989803174581
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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