MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-06-27 for CASTVAC W/8 FOOT HOSE AND MOBILE STAND 0986000000 manufactured by Stryker Instruments-kalamazoo.
[3869010]
It was reported that sparks came out of the castvac w/8 foot hose and mobile stand when it was used to suction water. There was no patient involvement and no adverse consequences associated with the device.
Patient Sequence No: 1, Text Type: D, B5
[11174294]
The reported event, used for water and sparks came out, was confirmed. During testing the service tech observed that the device was used for water, as visual inspection found the pc board, motor, rocker switch, mid and bottom canisters, and receptacle were all damaged due to water. The device is designed to vacuum dry material only. The ifu clearly states to not use the castvac to vacuum wet material, and if used as a wet vacuum the castvac could present an electrical shock hazard. Based on the risk assessment, ifu, and cases with similar reported events this failure can cause sparking and a possible shock to a user.
Patient Sequence No: 1, Text Type: N, H10
[21293564]
It was reported that sparks came out of the castvac w/8 foot hose and mobile stand when it was used to suction water. There was no patient involvement and no adverse consequences associated with the device.
Patient Sequence No: 1, Text Type: D, B5
[21484059]
The device has been received, but the evaluation has not yet begun. Additional information may be submitted once the quality investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0009616696-2013-00004 |
| MDR Report Key | 3192164 |
| Report Source | 06 |
| Date Received | 2013-06-27 |
| Date of Report | 2013-06-05 |
| Date of Event | 2013-06-03 |
| Date Mfgr Received | 2013-09-05 |
| Device Manufacturer Date | 2006-07-07 |
| Date Added to Maude | 2013-09-20 |
| 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. KATE LONGMAN |
| 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 | 2013-06-27 |
| Returned To Mfg | 2013-06-18 |
| Catalog Number | 0986000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2013-06-27 |