MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-03 for ULTRAVIEW SL MULTIGAS ANALYZER MODULE 91518 manufactured by Spacelabs Medical.
[1309919]
Spacelabs received a report that the monitoring system initially displayed the correct anesthesia gas mixture, then began to indicate that an unused gas, sevoflurane, was present.
Patient Sequence No: 1, Text Type: D, B5
[8342809]
Device evaluation anticipated, but not yet begun. Spacelabs has requested that the suspect device be returned to our facility for a detailed evaluation. Spacelabs is waiting to receive the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3023361-2009-00021 |
| MDR Report Key | 1571257 |
| Report Source | 05 |
| Date Received | 2009-12-03 |
| Date of Report | 2009-12-03 |
| Date of Event | 2009-11-03 |
| Date Mfgr Received | 2009-11-03 |
| Device Manufacturer Date | 2009-06-01 |
| Date Added to Maude | 2010-08-25 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DAVID GERAGHTY, MANAGER RA |
| Manufacturer Street | 5150 220TH AVE SE |
| Manufacturer City | ISSAQUAH WA 98029 |
| Manufacturer Country | US |
| Manufacturer Postal | 98029 |
| Manufacturer Phone | 4256577200 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRAVIEW SL MULTIGAS ANALYZER MODULE |
| Generic Name | ANESTHESIA GAS ANALYZER MODULE |
| Product Code | CBR |
| Date Received | 2009-12-03 |
| Model Number | 91518 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPACELABS MEDICAL |
| Manufacturer Address | 5150 220TH AVE SE ISSAQUAH WA 98029683 US 98029 6834 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-03 |