MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-14 for SPACELABS ARKON 99999 manufactured by Spacelabs Healthcare Inc..
[95067560]
During the fda daily pre-use checkout, the arkon anesthesia machine failed the o2 sensor calibration checkout. The machine was removed from service. Biomed then calibrated the o2 cell and re-tested / cleared the machine to return to service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073998 |
| MDR Report Key | 7120695 |
| Date Received | 2017-12-14 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-09-19 |
| Date Added to Maude | 2017-12-15 |
| 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 | SPACELABS |
| Generic Name | ANESTHESIA MACHINE ARKON |
| Product Code | DXH |
| Date Received | 2017-12-14 |
| Model Number | ARKON 99999 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPACELABS HEALTHCARE INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-14 |