MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-09 for CENTRAL WATER PLATFORM 103256 manufactured by Mar Cor Purification.
[18919862]
The cwp ro system would not power on and the electrical breaker was tripped. Reverse osmosis water could not be produced causing a delay in patient treatment.
Patient Sequence No: 1, Text Type: D, B5
[19275904]
Upon investigation the clinic technicians observed cracked, shorted and burnt wires in the control panel terminal block where the three phase power comes into the unit. Patient treatment was temporarily delayed for 1. 5 hours while the unit was being repaired. No patient/handler injuries or illnesses were reported. Mar cor purification will continue to monitor this complaint within the complaint system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3019131-2014-00026 |
| MDR Report Key | 4157260 |
| Report Source | 05,06 |
| Date Received | 2014-10-09 |
| Date of Report | 2014-10-09 |
| Date of Event | 2014-09-11 |
| Date Mfgr Received | 2014-09-11 |
| Device Manufacturer Date | 2013-05-10 |
| Date Added to Maude | 2014-10-21 |
| 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 | MEGAN DICKEY |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533327 |
| Manufacturer G1 | MAR COR PURIFICATION |
| Manufacturer Street | 14550 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CENTRAL WATER PLATFORM |
| Generic Name | REVERSE OSMOSIS SYSTEM |
| Product Code | FIP |
| Date Received | 2014-10-09 |
| Model Number | 103256 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAR COR PURIFICATION |
| Manufacturer Address | 14550 28TH AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-09 |