MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-01-18 for DEFINIUM 8000 manufactured by Ge Medical Systems, Llc.
[2513558]
It was reported that a pt barrier rotational handle lock was broken in a manner that prevented it from locking into position. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[9593179]
This malfunction was determined to be reportable as this same malfunction was previously contributed to a serious injury within the last two years. Reference mdr 2126677-2010-00010. Initial reporter occupation was not provided. Ge healthcare's investigation concluded that the mechanism which applies friction to the definium 8000 pt barrier pivoting arm wears rapidly allowing the arm to swing freely when the lock is not applied. The result is that the pivoting arm may be stored in an upright position which will be unstable due to a lack of residual friction. Ge healthcare will modify the rotating arms to restore the residual friction so that the arm will retain position (rather than swing freely) while the locking levers are disengaged. The product labeling will also be updated to improve awareness and identify the hazard relative to proper storage. This action has been reported to fda per 21 cfr part 806 on 1005/2011. Reference corrections and removals report number 2126677-10/5/11-002-c.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2012-00007 |
| MDR Report Key | 2436797 |
| Report Source | 06 |
| Date Received | 2012-01-18 |
| Date of Report | 2012-01-11 |
| Date of Event | 2012-01-11 |
| Date Mfgr Received | 2012-01-11 |
| Device Manufacturer Date | 2006-02-01 |
| Date Added to Maude | 2012-08-07 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE MEDICAL SYSTEMS, LLC |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2126677-10/5/11-002-C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEFINIUM 8000 |
| Generic Name | STATIONARY X-RAY SYSTEM |
| Product Code | IZF |
| Date Received | 2012-01-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS, LLC |
| Manufacturer Address | WAUKESHA WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-18 |