MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1999-09-30 for ANESTHETIC GAS MODULE M1026A manufactured by Agilent Technologies, Inc..
[159039]
The customer reported that they have had intermittent problems with this device. They reported that values have disappeared from time to time, white screen, a lot of moisture in the device, and no water trap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-1999-00127 |
| MDR Report Key | 242973 |
| Report Source | 05,06,07 |
| Date Received | 1999-09-30 |
| Date of Report | 1999-08-30 |
| Device Manufacturer Date | 1997-09-01 |
| Date Added to Maude | 1999-10-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JEAN SCHUBACH |
| Manufacturer Street | 3000 MINUTEMAN RD |
| Manufacturer City | ANDOVER MA 018101099 |
| Manufacturer Country | US |
| Manufacturer Postal | 018101099 |
| Manufacturer Phone | 9786593956 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANESTHETIC GAS MODULE |
| Generic Name | AGM |
| Product Code | CBQ |
| Date Received | 1999-09-30 |
| Model Number | M1026A |
| Catalog Number | M1026A |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 235398 |
| Manufacturer | AGILENT TECHNOLOGIES, INC. |
| Manufacturer Address | 3000 MINUTEMAN RD. ANDOVER MA 018101099 US |
| Baseline Brand Name | ANESTHETIC GAS MODULE |
| Baseline Generic Name | AGM |
| Baseline Model No | M1026A |
| Baseline Catalog No | M1026A |
| Baseline ID | NA |
| Baseline Device Family | PLUG-IN |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K951127 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-09-30 |