MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-06-29 for "FLOWMETER" OR MEDICAL GAS CONNECTOR manufactured by Chemtron (distributed By Allied Health Care).
[2584277]
Oxygen or air fittings disconnect at knurled fitting causing flowmeter to project from wall. This has the potential to injure users or pts. It also has the potential to discontinue the flow of oxygen to a pt who needs oxygen to survive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2527248 |
| MDR Report Key | 2527248 |
| Report Source | 99 |
| Date Received | 2010-06-29 |
| Date of Report | 2010-06-07 |
| Date Facility Aware | 2010-06-04 |
| Report Date | 2010-06-07 |
| Date Reported to FDA | 2010-06-17 |
| Date Added to Maude | 2012-04-13 |
| 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 | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | "FLOWMETER" OR MEDICAL GAS CONNECTOR |
| Generic Name | "FLOWMETER" OR MEDICAL GAS CONNECTOR |
| Product Code | CAX |
| Date Received | 2010-06-29 |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHEMTRON (DISTRIBUTED BY ALLIED HEALTH CARE) |
| Brand Name | "FLOWMETER" OR MEDICAL GAS CONNECTOR |
| Generic Name | "FLOWMETER" OR MEDICAL GAS CONNECTOR |
| Product Code | CAX |
| Date Received | 2010-06-29 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SUPERIOR PRODUCTS (DISTRIBUTED BY ALLIED HEALTH CARE) |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2010-06-29 |