MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS INTELLIVUE NMT MODULE; PATIENT MONITOR

Model Number 865383

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted once the investigation is complete.

Event Description

The customer reported that the patient cable of the neuromuscular transmission (nmt) module burned a patient at the measurement site on the patient¿s lower right arm during a time-of-flight (tof) measurement operation.The customer has alleged that the patient¿s burn was 3-5 cm in diameter and third-degree, but no report of scarring and/or nerve impact has been reported.The patient had ointment applied to the burn, was discharged from the hospital, and was recommended to visit a dermatologist as an outpatient.Philips has not received ay report of the burn worsening.

Manufacturer Narrative

Philips field service engineer (fse) visited the customer site, confirmed the reported issue and gathered information surrounding the event.The fse collected the damaged patient cable for return/evaluation and determined a replacement cable was needed.The fse provided a replacement cable and confirmed operational functionality, including a safety test, of the nmt module with the replacement cable.The damaged nmt module patient cable was removed from service and has since been returned to philips r&d for evaluation.Philips product support engineering (pse) inspected the returned cable and found that the sensor cable jacket had been damaged roughly 21 cm from the sensor and that the length of the tear in the cable jacket was around 12.5 mm.Under normal use according to the ifu (sensor attached to patient thumb) this position is consistent with the described location of the patient injury.Impressions on both sides of the tear in the cable jacket also provide evidence that the damage was a result of external force.Philips pse also inspected the cable under the microscope, which did not reveal any heat damage to the cable materials.There is no evidence to support that the damage was caused by an electrical discharge or increase in heat during the operation.In addition, the individual strands of the shield material are intact, and there are no broken shield strands which could have poked through the cable jacket.Philips pse also conducted a complaint search to see if related issues have been reported, and the search did not find any other issues related to burns.There is no indication that the break in the cable insulation was a result of a manufacturing issue.Based on the state of the cable and the information provided from the field, the cable appears to have been damaged prior to the start of the operation.If the cable jacket had been broken prior to the operation, the exposed shield would have been able to contact the patient¿s skin, creating an alternative path for the energy applied between the stimulation leads and resulting in a burn.Philips instructions for use (ifu) explicitly states that all cables and sensors must be examined prior to use and that damaged cables are not to be used.A philips field service engineer (fse) provided the customer a replacement cable and confirmed operational functionality, including a safety test, of the nmt module with the replacement cable.Philips has not received any report of the burn and/or the patient¿s condition worsening since the event occurred.No further investigation is required.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

• Brand Name: INTELLIVUE NMT MODULE
• Type of Device: PATIENT MONITOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; hewlett-packard str.2; boeblingen 71034 ; GM 71034
• MDR Report Key: 9646673
• MDR Text Key: 176954540
• Report Number: 9610816-2020-00038
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• PMA/PMN Number: K122439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/17/2020

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: 865383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 01/17/2020
• Supplement Dates FDA Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 47 YR