MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-29 for EXTRAPURG PORTABLE REVERSE OSMOSIS MACHINE DM-70 5M1313 manufactured by Baxter Healthcare Corp..
[21445]
This machine is supposed to clear chlorine and chloramine from water but it only clears chlorine. The carbon filter does not have the capacity to clear the chloramine. When the tech noticed the problem he called the mfr and the carbon filter was replaced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1008488 |
| MDR Report Key | 30623 |
| Date Received | 1996-02-29 |
| Date of Report | 1996-02-29 |
| Date Added to Maude | 1996-03-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTRAPURG PORTABLE REVERSE OSMOSIS MACHINE |
| Generic Name | WATER PURIFIER |
| Product Code | JRS |
| Date Received | 1996-02-29 |
| Model Number | DM-70 |
| Catalog Number | 5M1313 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 31683 |
| Manufacturer | BAXTER HEALTHCARE CORP. |
| Manufacturer Address | ROUND LAKE IL 60073 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-02-29 |