MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for OXIMETER manufactured by Ge Healthcare.
[70786996]
Patient Sequence No: 1, Text Type: N, H10
[70786997]
Patient was being monitored on nsatx secondary spo2 module on her left wrist. Module showed pulse search with waveform but not value, 3 dashes in place of value, and 3 stars. This continued for 2-3 minutes then reading returned but heart reading from spo2 did not match electrocardiogram (ecg). Heart rate (hr) on ecg was 167, spo2 hr was 180 and monitor showed motion detected. This continued for about 5 minutes then monitor read probe off, flat line for waveform, no value,and 3 dashes. It continued to read this for 2 minutes. Switched back to patient data module (pdm) and read well. About an hour later, the pdm read probe off, no value, and 3 dashes, and flat line for waveform. Removed nsatx from room and saved for investigation needs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6431480 |
| MDR Report Key | 6431480 |
| 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 |
| 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 |