MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-01 for SAFETY STATION PLUS TP-SS200 manufactured by Dornoch Medical.
[5834892]
It was initially reported that smoke was coming from the back of the safety station plus and the unit displayed error code 270106. Additional clinical follow-up identified that the unit began smoking at the start of the cleaning cycle. The hot water master valve was getting hot and smoking while there were visible burning wires and charred plastic. The customer shut off the unit completely and the sterile processing department used an alternative method to process the waste. It was confirmed that there was no harm involved.
Patient Sequence No: 1, Text Type: D, B5
[13349328]
The safety station plus was installed on (b)(4) 2008 and was last repaired on (b)(4) 2012 for a non-related issue. The device was not made available for eval or repair by zimmer surgical. The customer canceled service/repair on this device as they planned to order a new device. The customer's reported event could not be confirmed and a cause could not be determined. Please note that the device is overdue for preventative maintenance. Failure to follow the preventative maintenance schedule could lead to failures caused by normal use or wear.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1954182-2015-00001 |
| MDR Report Key | 4814533 |
| Report Source | 05 |
| Date Received | 2015-06-01 |
| Date of Report | 2015-05-18 |
| Date of Event | 2015-03-03 |
| Date Mfgr Received | 2015-05-18 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2015-06-26 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFETY STATION PLUS |
| Generic Name | SAFETY STATION PLUS |
| Product Code | FLH |
| Date Received | 2015-06-01 |
| Model Number | NA |
| Catalog Number | TP-SS200 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2015-06-01 |