MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-10-02 for ETR COUCH * manufactured by Varian Medical Systems, Uk Ltd..
[170252]
A radiation therapy threatment had been completed when the pt attempted to raise themselves and get off the treatment couch before the therapists had finished lowering it. During this movement the pt gripped the posterior support panel such that as pt sat up they lifted the panel up and moved it off of the channel or groove that holds it in place on the center beam of the couch assembly. Subsequently the panel began to slide to one side, causing the pt to lose their balance and fall to the floor, fracturing their hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2914292-2000-00003 |
| MDR Report Key | 299350 |
| Report Source | 05,06 |
| Date Received | 2000-10-02 |
| Date of Report | 2000-09-05 |
| Date of Event | 2000-09-05 |
| Date Mfgr Received | 2000-09-05 |
| Date Added to Maude | 2000-10-11 |
| 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 |
| Manufacturer Contact | DALE REYNOLDS |
| Manufacturer Street | 3100 HANSEN WAY, M/S E-055 |
| Manufacturer City | PALO ALTO CA 94306 |
| Manufacturer Country | US |
| Manufacturer Postal | 94306 |
| Manufacturer Phone | 6504246773 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETR COUCH |
| Generic Name | PATIENT SUPPORT ASSEMBLY |
| Product Code | JAI |
| Date Received | 2000-10-02 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | P/N 879225 |
| 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 | 289768 |
| Manufacturer | VARIAN MEDICAL SYSTEMS, UK LTD. |
| Manufacturer Address | GATWICK ROAD CRAWLEY, WEST SUSSEX UK RH10 2RG |
| Baseline Brand Name | ETR COUCH |
| Baseline Generic Name | PATIENT SUPPORT ASSEMBLY |
| Baseline Model No | * |
| Baseline Catalog No | * |
| Baseline ID | P/N 879225 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2000-10-02 |