MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-09-26 for DCTM DCTM 188E manufactured by Del Medical Imaging Corp..
[948926]
Counter weight cable came loose due to worn anchor pin in column causing columns to drop down.
Patient Sequence No: 1, Text Type: D, B5
[8196224]
Preliminary indications are that the malfunction may have been due to poor maintenance. The unit is out of service and is being returned for evaluation, and any additional results or information will be provided in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418964-2008-00001 |
| MDR Report Key | 1184181 |
| Report Source | 08 |
| Date Received | 2008-09-26 |
| Date of Report | 2008-09-26 |
| Date of Event | 2008-08-27 |
| Date Mfgr Received | 2008-08-28 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2009-02-09 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | WILLIAM KOSTECKI |
| Manufacturer Street | 11550 WEST KING ST. |
| Manufacturer City | FRANKLIN PARK IL 60131 |
| Manufacturer Country | US |
| Manufacturer Postal | 60131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DCTM |
| Generic Name | X-RAY CEILING TUBE MOUNT |
| Product Code | IYB |
| Date Received | 2008-09-26 |
| Model Number | DCTM |
| Catalog Number | DCTM 188E |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEL MEDICAL IMAGING CORP. |
| Manufacturer Address | FRANKLIN PARK IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-26 |