MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-09-18 for SAFETY STATION TP-SS100 manufactured by Dornoch Medical.
[20328302]
It was reported that smoke and sparks started to come out of the safety station. Additional follow up with the customer identified that the issue was observed at the time two of the maintenance employees were moving the unit away from the wall. While moving the unit, water dripped onto the service which led to the customer's reported issue. After the sparking occurred, the power was disconnected and the unit was taken to be examined. It was noted that the initially reported smoke may have been related to steam coming from water contact on the device. It was confirmed that at no point did sparking make contact with anyone handling the unit. There was no harm associated with the event.
Patient Sequence No: 1, Text Type: D, B5
[20566646]
The device was not returned to the manufacturer, but reviewed by service technician at the user facility. A follow up medwatch will be submitted once the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1954182-2014-00001 |
| MDR Report Key | 4202520 |
| Report Source | 06,07 |
| Date Received | 2014-09-18 |
| Date of Report | 2014-08-21 |
| Date of Event | 2014-08-21 |
| Date Mfgr Received | 2014-08-21 |
| Date Added to Maude | 2014-10-29 |
| 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 | KATHLEEN SMITH |
| Manufacturer Street | 200 NW PKWY. RD. |
| Manufacturer City | RIVERSIDE MO 64150 |
| Manufacturer Country | US |
| Manufacturer Postal | 64150 |
| Manufacturer Phone | 3303649447 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFETY STATION |
| Generic Name | SAFETY STATION |
| Product Code | FLH |
| Date Received | 2014-09-18 |
| Model Number | NA |
| Catalog Number | TP-SS100 |
| Lot Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DORNOCH MEDICAL |
| Manufacturer Address | 200 NW PKWY. RD. RIVERSIDE MO 64150 US 64150 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-18 |