MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2005-10-12 for 237-2120-300 manufactured by Scott Medical Products.
[441466]
Scott medical products produces calibration gas mixtures in aerosol style cylinders (7 inches tall x 2. 5 inches in diameter holding 4 liters of gas) for datex-ohmeda. The buyer from datex-ohmeda reported that the cylinder valve separated from the cylinder from a recent shipment releasing the gas. The cylinder was sitting on a storage shelf when the valve released.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518435-2005-00007 |
| MDR Report Key | 695473 |
| Report Source | 08 |
| Date Received | 2005-10-12 |
| Date of Report | 2005-10-12 |
| Date of Event | 2005-10-05 |
| Date Mfgr Received | 2005-10-05 |
| Device Manufacturer Date | 2005-09-01 |
| Date Added to Maude | 2006-04-06 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | JACK HENNE |
| Manufacturer Street | 6141 EASTON ROAD BUILDING #3 |
| Manufacturer City | PLUMSTEADVILLE PA 18949 |
| Manufacturer Country | US |
| Manufacturer Postal | 18949 |
| Manufacturer Phone | 2157668861 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | CALIBRATION GAS |
| Product Code | BXK |
| Date Received | 2005-10-12 |
| Returned To Mfg | 2005-10-06 |
| Model Number | NA |
| Catalog Number | 237-2120-300 |
| Lot Number | 527201 |
| ID Number | NA |
| Device Expiration Date | 2006-09-29 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 684601 |
| Manufacturer | SCOTT MEDICAL PRODUCTS |
| Manufacturer Address | * PLUMSTEADVILLE PA * US |
| Baseline Brand Name | NA |
| Baseline Generic Name | CALIBRATION GAS |
| Baseline Model No | NA |
| Baseline Catalog No | 237-2120-300 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-10-12 |