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

Model Number 989803174581

Device Problem Device Handling Problem (3265)

Patient Problem Burn(s) (1757)

Event Date 03/17/2023

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 314988899
• Report Number: 1218950-2023-00318
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838073715
• UDI-Public: 00884838073715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• 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
• Device Operator: Health Professional
• Device Model Number: 989803174581
• Device Catalogue Number: 989803174581
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 79 KG