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

Model Number 989803174581

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

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

Event Date 01/28/2023

Event Type  Injury  

Event Description

The customer reported that a frayed cable caused a patient burn upon contact to skin.The cable was immediately swapped out.A follow-up report will be submitted upon completion of the investigation.

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.

Manufacturer Narrative

Philips received a complaint on the intellivue nmt patient cable indicating there was a frayed cable that caused patient burn upon contact to skin.The patient underwent medical intervention to treat the reported skin burn.The patient's burn did not progress in depth, nor did the patient exhibit any new symptoms.The patient's burn was 2nd degree burn that was 1 cm in size on the thumb.The patient is doing well and has made a full recovery.The customer noted the cables were most likely damaged by cleaning with hydrogen peroxide and being accidentally run over by or equipment.The device was requested from the customer, but has not yet been returned for evaluation.Based on the information available and the testing conducted, the cause of the reported problem has not yet been confirmed.The reported problem was confirmed via interview/communication.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.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.At the time of the event, the damaged nmt cable was immediately swapped out.To prevent the same occurrence from happening again, the customer will be provided additional training.The customer was provided a replacement order for the nmt patient cables and a return materials authorization form (rma) to return the defective device back for 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, pending return/evaluation.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.

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).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 customer was provided a replacement order for the nmt patient cables.No further investigation or action is warranted at this time.

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

This supplemental is submitted for additional information with reference to manufacturer's report.Doc.Number: (b)(4).Further action decision: based on the information available and the results of additional analysis further action has been initiated.The nmt patient cables were returned to boblingen to be further evaluated.1.Objective: this report summarizes the outcome of the engineering design review with its systematic technical review (peer review) of specific design elements.Specific review objectives/items: review damages present in used nmt patient cables provided by customers as part of (b)(4).2.Available documentation: document name document no.Revision.N.A., review of physical cables n.A.N.A.The documentation available was adequate and sufficient to conduct the review.3.Observations / conclusions.3.1 burn mark at thumb.Location of observed injury at patient¿s thumb matches location of touchable shield wire protruding from damaged cable insulation when accelerometer is attached to patient¿s thumb.Cables returned from the customer, were manufactured april 2017.Even when considering substantial time between manufacturing and being brought to use in the customer environment, projected lifetime of approximately 18 months of use was already exceeded by far.Deterioration of bend relief features and overmolds of cable 1 used in the report can be associated to accumulated wear caused by disinfection or cleaning agents during that very long time span of use.The nmt patient cable has been verified to withstand cleaning and disinfection over the projected lifetime.Although the disinfectant reported to have been used in the hospital (cloroxpro wipes, based on dimethyl benzyl ammonium chloride as disinfecting agent) is not on the list of approved products, comparable disinfectants based on benzyl ammonium chloride are contained in verified brands.Therefore, the use of cloroxpro is not considered the cause of deteriorated details or parts in itself.Appearance of the cables can be explained by extension of use beyond anticipated lifetime and thereby much higher number of cleaning / disinfection cycles.In addition, and with high probability, the sensor section of the cable 1 used in the report has been altered at customer site by removing the positioning guides and possibly thereby damaging the cable sheath.This assumption is based on appearance of cable 2, where (while the coarse structures of orientation guides are missing) the fine structures of mold partition lines are still present.With chemically aggressive cleaning agents, the fine structures can be assumed to vanish first.3.2 burn marks at stimulation site.Burn marks at the energy transition site for stimulation currents can only happen with current density becoming too high and thus create excessive heat due to skin resistance.The instructions for use of monitor products capable of running the nmt measurement contain specifications of the minimum size of electrodes required for safely transferring stimulation energy which when used correctly limit current density to acceptable levels, safely preventing burns.In observed case, the customer has either used electrodes too small, or used electrodes with shelf life expired (not sticking to skin on whole surface) or failed in skin preparation.In addition, shown burns marks indicate that the customer did not follow the directions on placement of electrodes (2 cm distance, per application note on measuring nmt, (b)(4)).Cleaners and disinfectants: the nmt patient cable has been verified to withstand cleaning and disinfection for following products: brand / name major incredients dimethyl benzyl ammonium chloride.Isopropanol isopropanol no.Sodium hypochlorite bleach 1% sodium hypochloride no.Hydrogenic peroxide hydrogenic peroxide no.Bacillol 30 propan-1-ol 60 mg/g propan-2-ol 100mg/g ethanol 140 mg/g n-alkylaminopropylglycin 5mg/g no.Dismozon plus organic peroxide magnesium monoperoxyphthalat hexahydrat no.Meliseptol propan-2-ol didecyldimethylammoniumchlorid no, but somewhat comparable.Incidin foam propan-2-ol benzalkoniumchlorid no.Oxivir tb benzyl alcohol hydrogen peroxide no.Sani-cloth plus ethanol, isopropanol, didecyl dimethyl benzyl ammonium chloride yes.Super sani-cloth alkyl dimethyl benzyl ammonium chloride yes.Mikrozid sensitive wipes c12-14- alkyl[(ethylphenyl)methyl]dimethyl-, chloride no.Brand / name major incredients dimethyl benzyl ammonium chloride.Mikrozid paa wipes hydrogen peroxide, acetic acid no.Descogen liquid potassium peroxomonosulphate no.Lysoformin didecyldimethylammoniumchloride no, but somewhat comparable.Descosept pur ethanol no.Bazillol af propanol, ethanol no.

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.

• 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: 16692246
• MDR Text Key: 312808371
• Report Number: 1218950-2023-00192
• 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,Followup,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: 03/27/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 04/07/2023; 04/07/2023; 04/07/2023
• Supplement Dates FDA Received: 04/18/2023; 05/23/2023; 09/19/2023
• 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): Other
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Weight: 79 KG