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 1999-11-24 for ANESTHETIC GAS MODULE M1026A manufactured by Agilent Technologies, Gmbh.
[17513584]
The customer reported that a watertrap air leak resulted in low levels of monitored co2 and agent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610816-1999-00006 |
| MDR Report Key | 251788 |
| Report Source | 05,06,07 |
| Date Received | 1999-11-24 |
| Date of Report | 1999-10-25 |
| Date of Event | 1999-10-17 |
| Date Mfgr Received | 1999-10-25 |
| Device Manufacturer Date | 1996-12-01 |
| Date Added to Maude | 1999-12-02 |
| 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 ROAD |
| 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 | 1999-11-24 |
| Model Number | M1026A |
| Catalog Number | M1026A |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 243858 |
| Manufacturer | AGILENT TECHNOLOGIES, GMBH |
| Manufacturer Address | SCHICKARD STRASSE 4 BOEBLINGEN, BADEN-WTTBG GM D-71034 |
| 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 | 1999-11-24 |