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 2002-05-24 for ANESTHETIC GAS MODULE M1026A manufactured by Philips Medizinsysteme Boblingen Gmbh.
[21690300]
The customer reported that when using water trap (model m1657b) with the agm, the co2 waveform shows a rise during the inspiration cycle. This did not occur with the previous water trap model. The customer noted that this effect was evident when patient circuit pressures exceed 26 cm h2o.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610816-2002-00082 |
| MDR Report Key | 396955 |
| Report Source | 05,06,07 |
| Date Received | 2002-05-24 |
| Date of Report | 2002-04-26 |
| Date of Event | 2002-04-26 |
| Date Mfgr Received | 2002-04-26 |
| Date Added to Maude | 2002-05-31 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANESTHETIC GAS MODULE |
| Generic Name | AGM |
| Product Code | CBQ |
| Date Received | 2002-05-24 |
| 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 | 386001 |
| Manufacturer | PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH |
| Manufacturer Address | HERRENBERGER ST. 130 BOEBLINGEN GM D71034 |
| 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 | 2002-05-24 |