MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE NMT PATIENT CABLE

Model Number	989803174581
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This supplemental reported is submitted with reference to manufacturers report 1218950-2023-00219 to update patient impact and outcome coding.(b)(6) 2023: clinical reassessment was performed based on new information received in the complaint record.The burn was classified as a 2nd degree burn with blistering and not further treatment was required beyond the silvadene ointment.This information does not alter the previous assessment.
Event or Problem Description
Philips received a complaint from the anesthesia patient safety foundation (apsf) on the intellivue nmt patient cable sn unknown indicating a patient burn while in use.The burn happened when the patient came in contact with a damaged end of the cable.There was breakdown of the insulation at the accelerometer portion which was in contact with the patient¿s skin leading to an electrical short.On post-operative day (pod) 2, the anesthesia service was consulted to evaluate a blister on the patient¿s thumb.The patient had a second degree burn (partial thickness with a 1cm blister) on his ventral manuscript 2 thumb, as well as a region of skin breakdown over his ipsilateral ventral ulnar forearm.The injury was major and resolved with topical silver sulfadiazine (silvadene) ointment applications twice daily.
Additional Manufacturer Narrative
This record has been identified as a duplicate record with reference to manufacturers report 1218950-2023-00192 (manufacturers internal reference (b)(4)).This record will be closed with no further reporting.

• Brand Name: INTELLIVUE NMT PATIENT CABLE
• Common Device Name: INTELLIVUE NMT PATIENT CABLE
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 16910695
• Report Number: 1218950-2023-00318
• Device Sequence Number: 6170403
• Product Code: MHX
• UDI-Device Identifier: 00884838073715
• UDI-Public: 00884838073715
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 05/23/2023
• 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: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 79 KG