MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-02 for FALL MEDICAL Q POINT STERILIZING GRADE WATER FILTER QJ212A manufactured by Pall Corporation.
[126238105]
Point of use water filter used in pt room to control legionella pneumophila appeared to have failed. Mfr believes due to high water pressure event. Mfr inspection (b)(6) 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081037 |
| MDR Report Key | 8037885 |
| Date Received | 2018-11-02 |
| Date of Report | 2018-10-25 |
| Date of Event | 2018-05-12 |
| Date Added to Maude | 2018-11-05 |
| 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 | 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 | 0 |
| Brand Name | FALL MEDICAL Q POINT STERILIZING GRADE WATER FILTER |
| Generic Name | SYSTEM WATER PURIFICATION, GENERAL MEDICAL USE |
| Product Code | NHV |
| Date Received | 2018-11-02 |
| Model Number | QJ212A |
| Catalog Number | QJ212A |
| Lot Number | 18-3022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALL CORPORATION |
| Manufacturer Address | 25 HARBOR PARK DRIVE PORT WASHINGTON NY 11050 US 11050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-11-02 |