MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-10-14 for CM5000SC CM5000 SC 900-50SC-001 manufactured by Canadian Monaghan Limited.
[7505]
When the monitor was being set-up it would not; theneedle on the gauge was not moving. When the unit was tested in biomed (prior to being installed into a ventillator patient system) the needle would move irratically. The unit did not sound an inadvertent off alarm. The instruction manual has a procedure for the testing of the unit prior to use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317346-1993-00001 |
| MDR Report Key | 10874 |
| Date Received | 1993-10-14 |
| Date of Report | 1993-08-24 |
| Date of Event | 1993-07-06 |
| Date Facility Aware | 1993-07-06 |
| Report Date | 1993-08-13 |
| Date Reported to FDA | 1993-08-13 |
| Date Added to Maude | 1994-01-10 |
| 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 |
| Brand Name | CM5000SC |
| Generic Name | AIRWAY PRESSURE MONITOR |
| Product Code | CAP |
| Date Received | 1993-10-14 |
| Model Number | CM5000 SC |
| Catalog Number | 900-50SC-001 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 24 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10874 |
| Manufacturer | CANADIAN MONAGHAN LIMITED |
| Manufacturer Address | 220 ADELAIDE STREET SOUTH LONDON, ONTARIO CA N5Z 3L1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-10-14 |