MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-04-12 for SERIES S-750 ALTHIN PORTABLE RO 13200 manufactured by Osmonics, Inc. (zyzatech) / Kent Operations.
[15379912]
One wheel of the equipment fell off, causing the machine to tilt. The operator attempted to stop the machine from tilting, injuring her shoulder in the process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019131-2000-00004 |
| MDR Report Key | 274134 |
| Report Source | 06 |
| Date Received | 2000-04-12 |
| Date of Report | 1999-06-22 |
| Date of Event | 1999-06-22 |
| Date Mfgr Received | 1999-06-22 |
| Device Manufacturer Date | 1998-04-01 |
| Date Added to Maude | 2000-04-20 |
| 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 | PATRICK LYNCH |
| Manufacturer Street | 7848 S 202ND ST |
| 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 | SERIES S-750 ALTHIN PORTABLE RO |
| Generic Name | PORTABLE WATER PURIFICATION FOR HEMODIALYSIS, RO |
| Product Code | JRS |
| Date Received | 2000-04-12 |
| Model Number | S-750 |
| Catalog Number | 13200 |
| Lot Number | * |
| ID Number | CR 9906073 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 265347 |
| Manufacturer | OSMONICS, INC. (ZYZATECH) / KENT OPERATIONS |
| Manufacturer Address | 7848 SOUTH 202ND ST. KENT WA 98032 US |
| Baseline Brand Name | SERIES S-750 ALTHIN PORTABLE RO |
| Baseline Generic Name | PORTABLE WATER PURIFICATION FOR HEMODIALYSIS, RO |
| Baseline Model No | S-750 |
| Baseline Catalog No | 13200 |
| Baseline ID | CR 9906073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2000-04-12 |