MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-04-03 for S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT manufactured by Ge Healthcare Finland Oy.
[4681527]
Limited info provided. A report was received in which the e-nmt module provided implausible readings. Unk if the reported event occurred during pt use.
Patient Sequence No: 1, Text Type: D, B5
[12164537]
(b)(4): manufacturer date is unk. A f/u report will be submitted when the investigation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2014-00008 |
| MDR Report Key | 3853639 |
| Report Source | 01,08 |
| Date Received | 2014-04-03 |
| Date of Report | 2013-06-14 |
| Date Mfgr Received | 2014-03-04 |
| Date Added to Maude | 2014-06-20 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N GRANDVIEW BLVD |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE HEALTHCARE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT |
| Generic Name | STIMULATOR, NERVE, PERPHERAL, ELECTRIC |
| Product Code | KOI |
| Date Received | 2014-04-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-03 |