MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for NSATX manufactured by Ge Healthcare.
[70786745]
Patient Sequence No: 1, Text Type: N, H10
[70786746]
Patient was placed on new spo2 module per temporary update. (new spo2 probe was placed on patient at this time as well). The rn noticed that probe was not picking up or reading saturations, and was without waveform, during patient activity that may or may not have been accompanied by desaturation. Module on monitor did not alarm at this time. Unable to read saturation module until disconnected from temporary module and reconnected back to main patient data module (pdm).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6431454 |
| MDR Report Key | 6431454 |
| Date Received | 2017-03-24 |
| Date of Report | 2017-02-15 |
| Date of Event | 2017-01-31 |
| Report Date | 2017-02-03 |
| Date Reported to FDA | 2017-02-03 |
| Date Reported to Mfgr | 2017-02-03 |
| Date Added to Maude | 2017-03-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | NSATX |
| Generic Name | OXIMETER |
| Product Code | DPZ |
| Date Received | 2017-03-24 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 465 PAN AMERICAN DR. STE. 11 EL PASO TX 79907 US 79907 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |