MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2001-10-13 for OSMONICS F801 RO SYSTEM 12340 NA manufactured by Osmonics, Inc..
[231795]
User facility reports that the casters on the medical device are "collapsing" under rigorous use. Medical devices are transported to, and used at, 13 separate facilities.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2001-00001 |
| MDR Report Key | 356166 |
| Report Source | 05,06 |
| Date Received | 2001-10-13 |
| Date of Report | 2001-09-14 |
| Date Mfgr Received | 2001-09-14 |
| Date Added to Maude | 2001-10-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAULA WILKERSON |
| Manufacturer Street | 7848 SOUTH 202ND STREET |
| Manufacturer City | KENT WA 98032 |
| Manufacturer Country | US |
| Manufacturer Postal | 98032 |
| Manufacturer Phone | 2533952200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSMONICS F801 RO SYSTEM |
| Generic Name | REVERSE OSMOSIS WATER PURIFICATION SYSTEM FOR HEMODIALYSIS. |
| Product Code | JRS |
| Date Received | 2001-10-13 |
| Returned To Mfg | 2001-10-05 |
| Model Number | 12340 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | PART # 50017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 345395 |
| Manufacturer | OSMONICS, INC. |
| Manufacturer Address | 7848 SOUTH 202ND ST. KENT WA 98032 US |
| Baseline Brand Name | F-801 PORTABLE RO INSERT SYSTEM |
| Baseline Generic Name | PORTABLE REVERSE OSMOSIS WATER PURIFICATION FOR HEMODIALYSIS |
| Baseline Model No | 12340 |
| Baseline Catalog No | 12340 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-10-13 |