MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-07-20 for 700 SERIES PORTABLE RO SYSTEM 14524 manufactured by Zyzatech Water Systems, Inc..
[120595]
While moving a portable reverse osmosis machine in a dialysis unit, one of the wheels came off, and the machine tipped. The operator, in attempting to prevent the machine from falling over, sustained a back injury. The operator missed two days work, and was placed on modified work duty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-1998-00001 |
| MDR Report Key | 178685 |
| Report Source | 05,06 |
| Date Received | 1998-07-20 |
| Date of Report | 1998-06-19 |
| Date of Event | 1998-06-15 |
| Date Mfgr Received | 1998-06-19 |
| Device Manufacturer Date | 1998-03-01 |
| Date Added to Maude | 1998-07-27 |
| 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 | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 700 SERIES PORTABLE RO SYSTEM |
| Generic Name | REVERSE OSMOSIS WATER PURIFICATION FOR HEMODIALYSIS |
| Product Code | JRS |
| Date Received | 1998-07-20 |
| Model Number | 14524 |
| Catalog Number | 14524 |
| Lot Number | 303606 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 173745 |
| Manufacturer | ZYZATECH WATER SYSTEMS, INC. |
| Manufacturer Address | 7848 SOUTH 202ND ST. KENT WA 98198 US |
| Baseline Brand Name | 700 SERIES PORTABLE RO SYSTEM |
| Baseline Generic Name | REVERSE OSMOSIS WATER PURIFICATION FOR HEMODIALYSIS |
| Baseline Model No | 14524 |
| Baseline Catalog No | 14524 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-07-20 |