MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-08 for AGM M1019A * manufactured by Philips Medical.
[1482997]
The watertrap on it needs to be replaced frequently, most of the time the manifold seal comes out attached to the watertrap. It is a little piece that is not easy to see. This produces a leakage and the unit does not read the value of the gas measured. We contacted philip to address this issue. Manufacturer response (as per reporter) for anesthesia gas module, philips agmthey will look into this complaint
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649631 |
| MDR Report Key | 1649631 |
| Date Received | 2010-03-08 |
| Date of Report | 2010-03-08 |
| Date of Event | 2010-03-03 |
| Report Date | 2010-03-08 |
| Date Reported to FDA | 2010-03-08 |
| Date Added to Maude | 2010-04-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AGM |
| Generic Name | ANESTHESIA GAS MODULE |
| Product Code | CBQ |
| Date Received | 2010-03-08 |
| Model Number | M1019A |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-03-08 |