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

Model Number 989803174581

Device Problem Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/17/2023

Event Type  Injury  

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 minor and resolved with topical silver sulfadiazine (silvadene) ointment applications twice daily.

Manufacturer Narrative

A philips field service engineer (fse) went onsite to evaluate the devices in question.The report confirms that the insulation at the patient end was damaged leading to the burn injury and indicates that these devices should be inspected before use.The customer speculates the cord became damaged through rough use (being stepped on, or having a cart roll over the cable, with the sterilization/cleaning procedure after each case (hydrogen peroxide wipes).Based on the information available and the testing conducted, the cause of the reported problem was not confirmed.The cause of the reported problem was confirmed to be the breakdown of the insulation at the accelerometer portion which was in contact with the patient¿s skin leading to an electrical short.A clinical harm review was performed as there was a report of patient harm.Based on this information, on post-op day 2, the patient reported a blister on their thumb which was noted in pacu but he did not inform the nurse at the time.The blister/burn on the thumb and the blisters on the wrist matched the location of the nmt cable position on the skin during surgery.These locations on the cable were found to have an insulation breakdown with exposed wires visible.Pictures of the blisters/burns were provided, which appear to indicate a burn beyond a superficial first degree burn as there is a blanched area surrounding an opening in the skin, which is itself surrounded by significant erythema.Silvadene ointment was prescribed as a treatment.Based on the information and images received, it was determined this event meets the criteria for serious injury.The ifu includes commentary about inspecting the device before use.In this particular case, the providers did not recognize the damaged cable due to the way the device can be placed in several positions, it was only by chance that this complication did not occur with use in other patients.The accelerometer is cubical and it can be attached with any of four sides to the patient¿s thumb.Unfortunately, for this patient the wire contacted the skin directly.To prevent the same occurrence from happening again, there was a presentation at the physician group morbidity and mortality conference.Education of the anesthesia to technicians who turn over the ors after cases, and education of the anesthesia providers including crnas and residents.Philips reached out to customer to have the product returned for further evaluation.Without the material being returned, we are not able to perform an evaluation to determine the cause of the reported incident.The device remains at the customer site.No further investigation or action is warranted at this time.

• 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: 16745924
• MDR Text Key: 313359901
• Report Number: 1218950-2023-00219
• 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

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?: No
• 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: 04/14/2023
• 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