MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-07-22 for S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT manufactured by Ge Healthcare Finland Oy.
[4878593]
The customer reported the e-nmt-01 module provided inaccurate values. There was no reported patient consequence. It is unk at this time what type of sensor was being used with the device.
Patient Sequence No: 1, Text Type: D, B5
[12344732]
A follow up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2014-00014 |
| MDR Report Key | 4013958 |
| Report Source | 01,06 |
| Date Received | 2014-07-22 |
| Date of Report | 2014-06-27 |
| Date of Event | 2014-06-27 |
| Date Mfgr Received | 2014-06-27 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2014-08-26 |
| 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 | 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT |
| Product Code | KOI |
| Date Received | 2014-07-22 |
| 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 | 2014-07-22 |