MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2004-10-04 for ARTICULATING ARM FOR CEILING MOUNT SYSTEM NR 5787 manufactured by E-z-em, Inc..
[676141]
Customer reported that the articulating arm fell from the ceiling. It appeared that the metal plate that is bolted to the ceiling came loose. The technician removed it and no one was hit or injured.
Patient Sequence No: 1, Text Type: D, B5
[7852342]
The broken arm is being returned to e-z-em for evaluation. A final follow up report will be submitted once our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2411512-2004-00010 |
| MDR Report Key | 904966 |
| Report Source | 06,07 |
| Date Received | 2004-10-04 |
| Date of Report | 2004-08-31 |
| Date of Event | 2004-08-31 |
| Date Facility Aware | 2004-08-31 |
| Report Date | 2004-08-31 |
| Date Reported to Mfgr | 2004-08-31 |
| Date Mfgr Received | 2004-08-31 |
| Date Added to Maude | 2007-08-31 |
| 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 | 3 |
| Manufacturer Contact | GINA VOGELSBERG, MANAGER |
| Manufacturer Street | 717 MAIN STREET |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 8005444624 |
| Manufacturer G1 | E-Z-EM, INC. |
| Manufacturer Street | 717MAIN STREET |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11590 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTICULATING ARM FOR CEILING MOUNT SYSTEM |
| Generic Name | CT INJECTOR ACCESSORY |
| Product Code | FIH |
| Date Received | 2004-10-04 |
| Model Number | NR |
| Catalog Number | 5787 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 879805 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 717 MAIN STREET WESTBURY NY 11590 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-04 |