MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-13 for DSU-D 70-0285 manufactured by Nephros, Inc..
[95769045]
Patient Sequence No: 1, Text Type: N, H10
[95769046]
Nephros received a report from a user facility advising us that one of their ice machines tested positive with an unspecified species of bacteria. There were no reported adverse events or health issues connected with the positive result. Nephros dsu-h is an in-line water filter, class ii medical device that is placed before ice machines in health care facilities in order to retain bacteria, virus and endotoxin. The user facility routinely tests their water at the ice machine and found that there was positive bacteria detected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003337893-2017-00001 |
| MDR Report Key | 7112518 |
| Date Received | 2017-12-13 |
| Date of Report | 2017-10-30 |
| Date of Event | 2017-10-16 |
| Date Facility Aware | 2017-10-16 |
| Date Mfgr Received | 2017-10-17 |
| Device Manufacturer Date | 2015-10-29 |
| Date Added to Maude | 2017-12-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. HOLLIE JOHNSON |
| Manufacturer Street | 41 GRAND AVE |
| Manufacturer City | RIVER EDGE NJ 07661 |
| Manufacturer Country | US |
| Manufacturer Postal | 07661 |
| Manufacturer Phone | 7324034681 |
| Manufacturer G1 | NEPHROS, INC. |
| Manufacturer Street | 41 GRAND AVE. |
| Manufacturer City | RIVER EDGE NJ 07661 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07661 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DSU-D |
| Generic Name | SYSTEM, WATER PURIFICATION, GENERAL MEDICAL U |
| Product Code | NHV |
| Date Received | 2017-12-13 |
| Returned To Mfg | 2017-10-17 |
| Model Number | 70-0285 |
| Lot Number | PI15/0360 |
| Device Expiration Date | 2018-09-28 |
| Operator | BIOMEDICAL ENGINEER |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEPHROS, INC. |
| Manufacturer Address | 41 GRAND AVE RIVER EDGE NJ 07661 US 07661 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-13 |