MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-20 for CASTVAC W/8 FOOT HOSE AND MOBILE STAND 0986000000 manufactured by Stryker Instruments-kalamazoo.
[4016666]
It was reported that the castvac w/8 foot hose and mobile stand sparked and smoked while being used on a cut booth on the service production floor. There was no patient involvement and no adverse consequences associated with the device.
Patient Sequence No: 1, Text Type: D, B5
[4093061]
It was reported that the castvac w/8 foot hose and mobile stand sparked and smoked while being used on a cut booth on the service production floor. There was no patient involvement and no adverse consequences associated with the device.
Patient Sequence No: 1, Text Type: D, B5
[11358856]
Failure analysis is ongoing; additional information may be submitted once the results analysis is complete.
Patient Sequence No: 1, Text Type: N, H10
[11422190]
The reported events, device sparked and smoke came from the unit, were confirmed. During testing the service technician confirmed the customer comments, as through troubleshooting traces of sparks and smoke were observed. The tech found the motor had evidence of sparking and overheating, and the motor was identified as the primary failure. A motor failure can cause device functionality issues along with overheating, which can lead to sparking or smoke.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001811755-2013-02912 |
| MDR Report Key | 3478173 |
| Report Source | 07 |
| Date Received | 2013-11-20 |
| Date of Report | 2013-10-24 |
| Date of Event | 2013-10-24 |
| Date Mfgr Received | 2014-01-22 |
| Device Manufacturer Date | 1994-01-30 |
| Date Added to Maude | 2013-11-20 |
| 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 | MR. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| 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 |
| Generic Name | INSTRUMENT, CAST REMOVAL, AC-POWERED |
| Product Code | LGH |
| Date Received | 2013-11-20 |
| Returned To Mfg | 2013-10-25 |
| Catalog Number | 0986000000 |
| Operator | OTHER |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-20 |