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

Model Number	989803174581
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Blister (4537)
Date of Event	12/08/2023
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.Reporting address state - 03 reporting institution phone # -(b)(6).
Event or Problem Description
The customer reported that the system transducer has had excessive leakage current causing injury to the patient's thumb.The device was in use at the time of the event, there was an injury to the patient during the event reported.
Additional Manufacturer Narrative
Diagnostic/functional testing was performed at the philips authorized repair facility.Results of functional testing indicate that visual inspection of the device indicate there was a burn mark on the upper side of the housing.The visual inspection also indicate that two strands of shield wire protrude from the cable overmold.The philips authorized repair facility indicate that defect was located on the upper side of the sensor housing and that the wrong attachment of the sensor to patient¿s thump enabled the burns.

• 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: 18445604
• Report Number: 9610816-2024-00005
• Device Sequence Number: 6751657
• Product Code: MHX
• UDI-Device Identifier: 00884838029583
• UDI-Public: 00884838029583
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024
• 2 Devices were Involved in the Event: 1 2

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2015
• 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