MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-07-02 for CEILING TUBE MOUNT CH30GH * manufactured by Shimadzu Medical Systems.
[673747]
Tube stand does not extend for procedure that requires pt to stand (does not lower enough). Techs not aware that manually raising the tube does not allow the counter balance to retract properly. Service called and parts were ordered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 898294 |
| MDR Report Key | 898294 |
| Date Received | 2007-07-02 |
| Date of Report | 2007-07-02 |
| Date of Event | 2007-06-20 |
| Report Date | 2007-07-02 |
| Date Reported to FDA | 2007-07-02 |
| Date Added to Maude | 2007-08-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEILING TUBE MOUNT |
| Generic Name | X-RAY SYSTEM, TUBE MOUNT, CEILING |
| Product Code | IYB |
| Date Received | 2007-07-02 |
| Model Number | CH30GH |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 874690 |
| Manufacturer | SHIMADZU MEDICAL SYSTEMS |
| Manufacturer Address | 20101 SOUTH VERMONT AVENUE TORRANCE CA 905021328 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-02 |