MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-06-20 for WATER CHEK 938 CAT 938P-N manufactured by Criticare Systems, Inc..
[21399126]
Customer reports small artifact on capnogram waveform if ventilation pressure exceeds 25-30mmhg between the inspiration and expiration breathing cycle. Customer reported patient involvement, but no adverse patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183600-2002-00001 |
| MDR Report Key | 401655 |
| Report Source | 06 |
| Date Received | 2002-06-20 |
| Date of Report | 2002-06-20 |
| Date of Event | 2002-05-21 |
| Date Mfgr Received | 2002-05-21 |
| Device Manufacturer Date | 2002-01-01 |
| Date Added to Maude | 2002-06-27 |
| 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 | LEE PENTON |
| Manufacturer Street | 20925 CROSSROADS CIRCLE |
| Manufacturer City | WAUKESHA WI 53186 |
| Manufacturer Country | US |
| Manufacturer Postal | 53186 |
| Manufacturer Phone | 2627988282 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER CHEK |
| Generic Name | WATER CHEK |
| Product Code | CBS |
| Date Received | 2002-06-20 |
| Model Number | 938 |
| Catalog Number | CAT 938P-N |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 390694 |
| Manufacturer | CRITICARE SYSTEMS, INC. |
| Manufacturer Address | 20925 CROSSROADS CIRCLE WAUKESHA WI 53186 US |
| Baseline Brand Name | WATER CHEK |
| Baseline Generic Name | WATER CHEK |
| Baseline Model No | 938 |
| Baseline Catalog No | 938P-N |
| Baseline ID | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K942737 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-06-20 |