MAUDE Adverse Event Report: GE HEALTHCARE FINLAND OY E-NMT-01; STIMULATOR, NERVE, PERIPHERAL, ELECT

Model Number M1235165

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670)

Patient Problems Muscle Weakness (1967); Oversedation (1990); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Incident date: per the site reporter the event occurred in (b)(6) 2019.Device identification number and device evaluation: customer site cannot confirm specific device serial number in use during described event.(b)(4).Ge healthcare's investigation of the described event is ongoing at this time.A follow-up report will be submitted once the investigation has been completed.

Event Description

The customer reports that medical intervention was required to prevent permanent bodily harm due to administration of a paralytic agent based on inaccurate device readings.

Manufacturer Narrative

Ge healthcare's (gehc) investigation has been completed.It was initially reported that the customer had experienced difficulties in using the e-nmt module.The e-nmt module was installed in (b)(6) 2019; the customer site elected to perform their own training.It was noted that in (b)(6) 2019, a user admittedly did not obtain baseline tof (train of four) values before paralytic medications were administered thus the tof value was not correlating to the hand twitch count.The device was determined to be functioning as designed, no indication of hardware/software malfunction.After providers began voicing concern over the functionality of e-nmt modules, multiple training sessions were offered on site for providers by gehc.The customer did not describe any adverse events related to this issue until filing a medwatch report.In report 2100090000-2020-8005 the customer describes their providers reporting mismatches between the bar graph depiction and percentage displayed for degree of neuromuscular block while utilizing the e-nmt module.Per the customer this led to over-administration of paralytic agents due to false indication that patient is inadequately paralyzed.In follow-up communication it was learned that patient 2 required increased monitoring, additional medications (neuromuscular blockade reversal agents), increased respiratory support (prolonged time on ventilator).The patient required counseling for awareness under anesthesia; no long term physical injury.Root cause of this event was determined to be due to use error (customer-delivered training, not obtaining a reference value prior to starting, use of non-qualified electrodes).

• Brand Name: E-NMT-01
• Type of Device: STIMULATOR, NERVE, PERIPHERAL, ELECT
• Manufacturer (Section D): GE HEALTHCARE FINLAND OY; kuortaneenkatu 2; helsinki FIN-0 0510; FI FIN-00510
• MDR Report Key: 9957669
• MDR Text Key: 187566733
• Report Number: 9610105-2020-00005
• Device Sequence Number: 1
• Product Code: KOI
• Combination Product (y/n): N
• PMA/PMN Number: K051635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M1235165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 74