MAUDE Adverse Event Report: MAR COR MARCOR; WATER TREATMENT SYSTEM

Model Number CWP 100 H/P

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2015

Event Type  Injury  

Event Description

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.

• Brand Name: MARCOR
• Type of Device: WATER TREATMENT SYSTEM
• Manufacturer (Section D): MAR COR; plymouth MN 55447
• MDR Report Key: 5249619
• MDR Text Key: 32205949
• Report Number: MW5058085
• Device Sequence Number: 1
• Product Code: FIP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CWP 100 H/P
• Device Catalogue Number: WTW620018003
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention