NMT NEUROMUSCULAR TRAN E-NMT-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for NMT NEUROMUSCULAR TRAN E-NMT-01 manufactured by Ge Healthcare.

Event Text Entries

[183271747] Device requires manual calibration prior to initiation of monitoring. Providers report mismatch between bar graph depiction and percentage displayed for degree of neuromuscular block. Independent verification of degree of block using alternate train of four devices indicates nmt may be oversensing muscular response, which leads to over-administration of paralytic agents due to false indication that patient is inadequately paralyzed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9828843
MDR Report Key9828843
Date Received2020-03-13
Date of Report2020-03-11
Date of Event2019-08-03
Report Date2020-03-11
Date Reported to FDA2020-03-11
Date Reported to Mfgr2020-03-13
Date Added to Maude2020-03-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNMT NEUROMUSCULAR TRAN
Generic NameSTIMULATOR, NERVE, PERIPHERAL, ELECTRIC
Product CodeKOI
Date Received2020-03-13
Model NumberE-NMT-01
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Age3 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerGE HEALTHCARE
Manufacturer Address3000 N. GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-13

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