MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-03-05 for F-801 PORTABLE RO INSERT SYSTEM 12340 manufactured by Zyzatech Water Systems, Inc..
[131260]
Complainant stated that, over a period of time, one of co's products had "tipped over", causing injury to an operator who was trying to prevent it from falling. The complainant stated that this event has occurred several times, causing injury to three operators. Allegedly, one of the injuries is permanent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-1999-00001 |
| MDR Report Key | 213275 |
| Report Source | 06 |
| Date Received | 1999-03-05 |
| Date of Report | 1999-02-09 |
| Date of Event | 1999-02-09 |
| Date Mfgr Received | 1999-02-09 |
| Date Added to Maude | 1999-03-11 |
| 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 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | F-801 PORTABLE RO INSERT SYSTEM |
| Generic Name | PORTABLE REVERSE OSMOSIS WATER PURIFICATION FOR HEMODIALYSIS |
| Product Code | JRS |
| Date Received | 1999-03-05 |
| Model Number | 12340 |
| Catalog Number | 12340 |
| Lot Number | NA |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 206930 |
| Manufacturer | ZYZATECH WATER SYSTEMS, 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. Deathisabilit | 1999-03-05 |