MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-11-01 for CM5000 81100 manufactured by Canadian Monaghan Limited.
[8075]
Home health caare worker removed one airway pressure monitor and connected unit returned from repair, prior to operational check-out, to patient. Unit failed to alaarm when patient stopped breathing. Patient turned blue but was attended to by the home health care worker estimates that one minute passed from the time she noticed the atient in distress. The patient is mentally retardedd with multiple health problems. Currently being treated for respiratory ailment which has produced thick secretions which th ehealth care worker states blocked the trach.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317346-1993-00003 |
| MDR Report Key | 10424 |
| Date Received | 1993-11-01 |
| Date of Report | 1993-09-10 |
| Date of Event | 1993-08-26 |
| Date Facility Aware | 1993-08-26 |
| Report Date | 1993-09-08 |
| Date Reported to Mfgr | 1993-09-08 |
| Date Added to Maude | 1993-12-13 |
| 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 | CM5000 |
| Generic Name | AIRWAY PRESSURE MONITOR |
| Product Code | CAP |
| Date Received | 1993-11-01 |
| Model Number | CM5000 |
| Catalog Number | 81100 |
| Lot Number | H1150 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10424 |
| Manufacturer | CANADIAN MONAGHAN LIMITED |
| Manufacturer Address | 220 ADELAIDE STREET SOUTH LONDON, ONTARIO CA N5Z 3L1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1993-11-01 |