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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAR COR PURIFICATION, INC. CWP 100 SUBSYSTEM, WATER PURIFICATION

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MAR COR PURIFICATION, INC. CWP 100 SUBSYSTEM, WATER PURIFICATION Back to Search Results
Model Number RO, CWP, 28 LPM, 104H
Device Problems Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/13/2017
Event Type  malfunction  
Event Description
For about 2 weeks, it was reported that there had been repetitive low level inlet pressure alarms overnight and the green operations indicator light would not come on. Due to these issues, the water purification unit could not be used and the back-up deionization system was used to purify the water. The system was serviced by the manufacturer 4 times during the 2 week period. Services performed by the manufacturer included changing the pre-treatment back wash timer settings, replacing the low level switch for the hot water tank, tightening the jumper bar, and replacing valve 64. Reportedly, the water purification unit has not had any issues since the last service when the jumper bar was tightened. Reportedly, no harm occurred to patients during the 2 week period.
 
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Brand NameCWP 100
Type of DeviceSUBSYSTEM, WATER PURIFICATION
Manufacturer (Section D)
MAR COR PURIFICATION, INC.
14550 28th avenue north
minneapolis MN 55447
MDR Report Key6405704
MDR Text Key69978622
Report Number6405704
Device Sequence Number1
Product Code FIP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRO, CWP, 28 LPM, 104H
Other Device ID Number100474
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/22/2017
Device Age16 MO
Event Location Hospital
Date Report to Manufacturer02/22/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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