MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-08-15 for CASTVAC W/8 FOOT HOSE AND MOBILE STAND 0986000000 manufactured by Stryker Instruments Kalamazoo.
[2262750]
It was reported that blue and orange flames came out of the cannister while in use. There was no patient involvement. There were no adverse consequences reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[9261843]
The castvac was received at the mfr for evaluation, but based on the investigation details the reported condition of flames coming out of the device while running could not be duplicated. It was found that the filter is bad, which let cast dust into the device and caused damage. Service and maintenance were completed on the device, and it was returned to the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2011-02974 |
| MDR Report Key | 2219062 |
| Report Source | 06 |
| Date Received | 2011-08-15 |
| Date of Report | 2011-07-25 |
| Date of Event | 2011-07-20 |
| Date Mfgr Received | 2011-07-25 |
| Device Manufacturer Date | 1993-04-20 |
| Date Added to Maude | 2011-09-29 |
| 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 Contact | GREGORY GOHL |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CASTVAC W/8 FOOT HOSE AND MOBILE STAND |
| Product Code | LGH |
| Date Received | 2011-08-15 |
| Returned To Mfg | 2011-07-29 |
| Catalog Number | 0986000000 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-15 |