MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-06 for PHILIPS M1657B * manufactured by Philips Medical Systems.
[280272]
New style water trap used with anesthesia gas analyzer causes artifact on the co2 waveform. The artifact appears as a small spike during the inhalation phase. The artifact occurs with high airway pressures, usually over 26 to 30 cmh20 peak pressure. Anesthetists may interpret this as an attempt by the pt to breathe, and they may adjust their drug dose based upon this artifact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024981 |
| MDR Report Key | 393735 |
| Date Received | 2002-05-06 |
| Date of Report | 2002-05-06 |
| Date Added to Maude | 2002-05-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHILIPS |
| Generic Name | WATER TRAP |
| Product Code | CBC |
| Date Received | 2002-05-06 |
| Model Number | M1657B |
| Catalog Number | * |
| Lot Number | ALL |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 382752 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN RD ANDOVER MA 01810 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-05-06 |