MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-05-14 for AIRWAY PRESSURE MONITOR CM5000SC 900-50SC-001 manufactured by Monaghan Medical Corp..
[22374]
Airway pressure monitor was reported to have failed to exhibit low pressure alarm condition when pt circuit become dislodged from the tracheal tube. An attending therapist re-connected breathing circuit without any further incident. Device was not properly set up prior to operation. Unit was subsequently set up according to mfr's specs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317346-1996-00001 |
| MDR Report Key | 34078 |
| Date Received | 1996-05-14 |
| Date of Report | 1996-05-14 |
| Date of Event | 1996-04-26 |
| Date Facility Aware | 1996-04-26 |
| Report Date | 1996-05-14 |
| Date Reported to FDA | 1996-05-14 |
| Date Reported to Mfgr | 1996-05-14 |
| Date Added to Maude | 1996-07-16 |
| 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 | AIRWAY PRESSURE MONITOR |
| Generic Name | AIRWAY PRESSURE MONITOR |
| Product Code | CAP |
| Date Received | 1996-05-14 |
| Model Number | CM5000SC |
| Catalog Number | 900-50SC-001 |
| Lot Number | Q583 |
| ID Number | D96-00110 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 17 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 35416 |
| Manufacturer | MONAGHAN MEDICAL CORP. |
| Manufacturer Address | 220 ADELAIDE ST SOUTH LONDON, ONTARIO CA N5Z3L1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-05-14 |