MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-10-08 for CENTRAL MONITORING SYSTEM CM5000SC 900-50SC-001 manufactured by Canadian Monaghan Limited.
[5216]
Patient pulled out her shiley trach while connected to a life care lp-6 central monitoring system. Resident's nurse walked in and found patient turning blue. Staff inable to ventilate patient as whole trach system was pulled out, leaving nothing to connect ambubag to. Nurse states alarm was not sounding on airway pressure monitor or ventliator. Patient died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317346-1993-00002 |
| MDR Report Key | 10242 |
| Date Received | 1993-10-08 |
| Date of Report | 1993-09-14 |
| Date of Event | 1993-08-10 |
| Date Facility Aware | 1993-08-10 |
| Report Date | 1993-08-30 |
| Date Reported to FDA | 1993-08-30 |
| Date Reported to Mfgr | 1993-08-30 |
| Date Added to Maude | 1993-10-15 |
| 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 | CENTRAL MONITORING SYSTEM |
| Generic Name | AIRWAY PRESSURE MONITORING SYSTEM |
| Product Code | CAP |
| Date Received | 1993-10-08 |
| Model Number | CM5000SC |
| Catalog Number | 900-50SC-001 |
| Lot Number | P344N |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10242 |
| Manufacturer | CANADIAN MONAGHAN LIMITED |
| Manufacturer Address | 220 ADELAIDE STREET SOUTH LONDON, ONTARIO CA N5Z 3L1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1993-10-08 |