MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-03 for E-SCAIO E-SCAIO-00 manufactured by Ge Healthcare.
[116293356]
Etco2 reader displayed error message, machine would not pick up etco2 or et for inhalation agent. Machine had passed check before case. Also, daily check.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078877 |
| MDR Report Key | 7752551 |
| Date Received | 2018-08-03 |
| Date of Report | 2018-08-01 |
| Date of Event | 2018-07-21 |
| Date Added to Maude | 2018-08-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | E-SCAIO |
| Generic Name | ANALYZER, GAS, OXYGEN, GASEOUS |
| Product Code | CCL |
| Date Received | 2018-08-03 |
| Model Number | E-SCAIO-00 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | WAUWATOSA WI 53226 US 53226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-03 |