MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-11-03 for ARM & BRACKET ASSY * 241047 manufactured by Mallinckrodt Inc., Liebel-flarsheim Business.
[351807]
A ct technologist had complete a test using a ceiling mounted ct contrast injector near a patient for use. With the device moved away from the patient the tech was removing a syringe from the injector device when a pivot arm on the suspension system for the device snapped off, causing a section of approx 20 lbs to dislodge and fall to the floor after striking the technologist in the head, knocking off the tech's glasses. The tech sustained minor injuries as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1518293-2004-00019 |
| MDR Report Key | 553550 |
| Report Source | 07 |
| Date Received | 2004-11-03 |
| Date of Report | 2004-10-21 |
| Date Mfgr Received | 2004-10-21 |
| Date Added to Maude | 2004-11-08 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DAVE BENSON |
| Manufacturer Street | 2111 E. GALBRAITH RD. |
| Manufacturer City | CINCINNATI OH 45237 |
| Manufacturer Country | US |
| Manufacturer Postal | 45237 |
| Manufacturer Phone | 5139485719 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARM & BRACKET ASSY |
| Generic Name | SUSPENSION SYSTEM |
| Product Code | IYB |
| Date Received | 2004-11-03 |
| Model Number | * |
| Catalog Number | 241047 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 543157 |
| Manufacturer | MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
| Manufacturer Address | 2111 EAST GALBRAITH RD. CINCINNATI OH 45237 US |
| Baseline Brand Name | ARM & BRACKET ASSY |
| Baseline Generic Name | SUSPENSION SYSTEM |
| Baseline Model No | * |
| Baseline Catalog No | 241047 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-11-03 |