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 TRANSMISSION E-NMT-01 manufactured by Ge Healthcare.
[183271406]
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
| Report Number | 9828800 |
| MDR Report Key | 9828800 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-08-26 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-13 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NMT NEUROMUSCULAR TRANSMISSION |
| Generic Name | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
| Product Code | KOI |
| Date Received | 2020-03-13 |
| Model Number | E-NMT-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 3000 N. GRANDVIEW BLVD. WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-13 |