MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-01-24 for AMVEX OXYGEN ADAPTER * ADCHODM manufactured by Ohio Medical Corporation.
[3284218]
The quick connect did not appear damaged before leaving for transport with patient. It was fine until respiratory therapist (rt) unplugged it from the oxygen source and the thing completely came apart. The green plastic piece came apart from the big silver piece. This item was removed from service and another quick connect was obtained. There was no harm to the patient. What was the original intended procedure? Transport with oxygen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2938979 |
| MDR Report Key | 2938979 |
| Date Received | 2013-01-24 |
| Date of Report | 2013-01-24 |
| Date of Event | 2013-01-14 |
| Report Date | 2013-01-24 |
| Date Reported to FDA | 2013-01-24 |
| Date Reported to Mfgr | 2013-02-01 |
| Date Added to Maude | 2013-02-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | AMVEX OXYGEN ADAPTER |
| Generic Name | REGULATOR, PRESSURE |
| Product Code | CCL |
| Date Received | 2013-01-24 |
| Model Number | * |
| Catalog Number | ADCHODM |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL CORPORATION |
| Manufacturer Address | 1111 LAKESIDE DRIVE GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-24 |