MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-30 for CM5000NG 81200NG manufactured by Canadian Monaghan Limited.
[20240965]
Unit will not alarm upon disconnect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317346-1995-00001 |
| MDR Report Key | 22620 |
| Date Received | 1995-01-30 |
| Date of Report | 1995-01-13 |
| Report Date | 1995-01-13 |
| Date Reported to FDA | 1995-01-13 |
| Date Reported to Mfgr | 1995-01-13 |
| Date Added to Maude | 1995-06-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | AIRWAY PRESSURE MONITOR |
| Product Code | CAP |
| Date Received | 1995-01-30 |
| Model Number | CM5000NG |
| Catalog Number | 81200NG |
| Lot Number | Q281 |
| ID Number | 94-347 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 22805 |
| Manufacturer | CANADIAN MONAGHAN LIMITED |
| Manufacturer Address | 220 ADELAIDE ST, SO. LONDON ONTARIO CA N5Z 3L1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-01-30 |