MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-01-18 for OXYGEN FLOWMETER W/DISS FITTING 7700 SERIES 7702-1261-921 manufactured by Ohio Medical Corporation.
[3173567]
The user facility reported to (b)(4) medical employee (b)(4) on (b)(6) 2012, that the power takeoff on their 02 flowmeter came loose when disconnecting the vent hose. The power takeoff flew across the room and a gust of oxygen (50 psi) from the outlet hit the tech in the ear, causing temporary hearing loss (the tech filed a complaint with the hospital).
Patient Sequence No: 1, Text Type: D, B5
[10511784]
The oxygen flowmeter with a diameter index safety system (diss) power outlet fitting is intended to allow the user to connect a peripheral hose to obtain line pressure for other medical devices that the user may choose to connect to the diss outlet. Per a follow-up telephone conversation on (b)(4) 2013 with an (b)(4) medical corporation engineer and the (b)(6) hospital, the following was noted by the risk manager: that the check diss outlet would come off the extension when they unscrewed the hose attached to the outlet. A preliminary investigation indicated that the diss fitting may loosen from the outlet extension when the user attempts to disconnect a hose from the diss fitting.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419185-2012-00004 |
| MDR Report Key | 2974315 |
| Report Source | 06 |
| Date Received | 2013-01-18 |
| Date of Report | 2013-01-17 |
| Date Mfgr Received | 2012-12-17 |
| Device Manufacturer Date | 2012-03-08 |
| Date Added to Maude | 2013-04-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1111 LAKESIDE DR. COMPLAINTS DEPARTMENT |
| Manufacturer City | GURNEE IL 60031 |
| Manufacturer Country | US |
| Manufacturer Postal | 60031 |
| Manufacturer Phone | 8478550500 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN FLOWMETER W/DISS FITTING |
| Generic Name | OXYGEN FLOWMETER |
| Product Code | CAX |
| Date Received | 2013-01-18 |
| Model Number | 7700 SERIES |
| Catalog Number | 7702-1261-921 |
| Lot Number | NA |
| ID Number | THER0057024 - 57160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO MEDICAL CORPORATION |
| Manufacturer Address | 1111 LAKESIDE DR. GURNEE IL 60031 US 60031 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-01-18 |