MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-08-10 for MEDICAL GAS YOKE ASSEMBLY AGI 2237 manufactured by Western Medica.
[15151347]
Airgas received a report of a potential nonconformity involving the medical gas yoke assemblies that are components of the manifold block assemblies on portable 2-cylinder and 4-cylinder manifold carts that are sold by airgas. Airgas was made aware by the mfr of the manifold carts, western/(b)(4), that in certain use situations, and in combination with various factors, the yoke pins may become displaced to such a degree that a post valve of one gas type could become interchangeable with a yoke connection of another gas type (i. E. , an oxygen cylinder become attached to a nitrous oxide yoke). Should this condition occur, the yoke index safety system could become compromised and the potential exists for a user to attach the wrong gas type to the yoke connection. To date, airgas has not received any reports of such an improper connection or any reports of a pt being exposed to an incorrectly-connected medical gas system.
Patient Sequence No: 1, Text Type: D, B5
[15298770]
The unit involved in this event was manufactured and distributed by western. Western is submitting its own mdr for this event. However, pursuant to a pre-existing written agreement between airgas and western, airgas is submitting this mdr. As the mfr of the yoke assemblies, western is responsible for the investigation of the underlying event. To address this matter and remedy to situation, western has designed a back-up plate to be installed between the medical gas yoke assembly and the manifold block to which it is attached. Once installed, the back-up plate serves as a positive stop for the yoke pins, preventing them from being displaced, and thereby maintaining the integrity of the yoke pin index safety system. Airgas is retrieving and replacing all of the manifold block assemblies which are components of the two (2) and four (4) cylinder portable manifold cart that are distributed under the following part number: agi 2237, portable 2-cylinder manifold cart. Please see report #: 1526809-2009-00003.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1526809-2009-00002 |
| MDR Report Key | 2677049 |
| Report Source | 00 |
| Date Received | 2009-08-10 |
| Date of Report | 2009-05-11 |
| Date of Event | 2008-11-21 |
| Date Mfgr Received | 2008-11-21 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2012-08-02 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 875 BASSETT RD. |
| Manufacturer City | WESTLAKE OH 441451142 |
| Manufacturer Country | US |
| Manufacturer Postal | 441451142 |
| Manufacturer Phone | 8007837890 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | AIGAS 08/05/2009-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICAL GAS YOKE ASSEMBLY |
| Generic Name | MEDICAL GAS YOKE ASSEMBLY |
| Product Code | CAM |
| Date Received | 2009-08-10 |
| Model Number | AGI 2237 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WESTERN MEDICA |
| Manufacturer Address | 875 BASSETT RD. WESTLAKE OH 44145114 US 44145 1142 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-08-10 |