MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-19 for MARCOR CWP 100 H/P WTW620018003 manufactured by Mar Cor.
[32205949]
There was an electronic solenoid valve coil on the new water treatment system which became too hot and gave off substantial odor (electrical burning smell) with some smoke in the (b)(6) water equipment room, not in the pt treatment area. The building fire alarm system was activate by a (b)(6) team member who activated a pull station in the hallway outside of (b)(6) and pt were evacuated into the hallway in order to ensure their safety. Pt treatment was interrupted for a brief period during this time. This was a repeat of a similar event in (b)(6) 2015. In both events the overheated coil was replaced with a spare immediately and the system placed back online. The equipment manufacturer, marcor, is actively pursuing a solution to this apparent design flaw. There was a related product recall alert on a similar device failure but it was confirmed that neither of these devices were included in the recall. We have filed a complaint to marcor recommending that this device should also be included in the recall and an alternative should be identified asap.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058085 |
| MDR Report Key | 5249619 |
| Date Received | 2015-11-19 |
| Date of Report | 2015-11-19 |
| Date of Event | 2015-05-16 |
| Date Added to Maude | 2015-11-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MARCOR |
| Generic Name | WATER TREATMENT SYSTEM |
| Product Code | FIP |
| Date Received | 2015-11-19 |
| Model Number | CWP 100 H/P |
| Catalog Number | WTW620018003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR |
| Manufacturer Address | PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-11-19 |