MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-15 for CWP 100 RO, CWP, 28 LPM, 104H manufactured by Mar Cor Purification, Inc..
[69978621]
Patient Sequence No: 1, Text Type: N, H10
[69978622]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6405704 |
| MDR Report Key | 6405704 |
| Date Received | 2017-03-15 |
| Date of Report | 2017-02-22 |
| Date of Event | 2017-01-13 |
| Report Date | 2017-02-22 |
| Date Reported to FDA | 2017-02-22 |
| Date Reported to Mfgr | 2017-02-22 |
| Date Added to Maude | 2017-03-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CWP 100 |
| Generic Name | SUBSYSTEM, WATER PURIFICATION |
| Product Code | FIP |
| Date Received | 2017-03-15 |
| Model Number | RO, CWP, 28 LPM, 104H |
| ID Number | 100474 |
| Device Availability | * |
| Device Age | 16 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR PURIFICATION, INC. |
| Manufacturer Address | 14550 28TH AVENUE NORTH MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-15 |