MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-12-29 for E-NMT manufactured by Ge Healthcare Finland Oy.
[5236748]
The customer reported an e-nmt module being used with an electrosensor provided inaccurate values. No patient injury occurred.
Patient Sequence No: 1, Text Type: D, B5
[12608010]
Ge healthcare's investigation is ongoing. A follow-up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[25148804]
The faulty e-nmt-01 module was replaced in december 2014 with a new e-nmt-01 module. The faulty e-nmt-01 module was received with the description of "the module shows incorrect values". The faulty e-nmt-01 module is addressed with recall number z-1640-2014. The reported issue of e-nmt-01 module showing incorrect values with electrosensor is a known issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2014-00021 |
| MDR Report Key | 4366575 |
| Report Source | 01 |
| Date Received | 2014-12-29 |
| Date of Report | 2014-12-05 |
| Date of Event | 2014-12-05 |
| Date Mfgr Received | 2015-02-06 |
| Device Manufacturer Date | 2013-11-01 |
| Date Added to Maude | 2015-01-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEB LAHR |
| Manufacturer Street | 540 W. NORTHWEST HWY |
| Manufacturer City | BARRINGTON IL 60010 |
| Manufacturer Country | US |
| Manufacturer Postal | 60010 |
| Manufacturer Phone | 8472774472 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer Street | KUORTANEENKATU 2 |
| Manufacturer City | HELSINKI, 510 |
| Manufacturer Country | FI |
| Manufacturer Postal Code | 510 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-1640-2014 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-NMT |
| Generic Name | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC |
| Product Code | KOI |
| Date Received | 2014-12-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | KUORTANEENKATU 2 HELSINKI, FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-29 |