MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-20 for DEFINIUM 8000 manufactured by Ge Medical Systems, Llc.
[15213500]
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. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
[15722429]
This malfunction was determined to be reportable as this same malfunction has previously contributed to a serious injury within the last two years. Reference mdr 2126677-2010-00010.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2126677-2011-00137 |
| MDR Report Key | 2324823 |
| Report Source | 06 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-10-20 |
| Date of Event | 2011-09-23 |
| Date Mfgr Received | 2011-09-23 |
| Device Manufacturer Date | 2006-09-01 |
| Date Added to Maude | 2012-07-06 |
| 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. MAIL CODE: 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 | LZI |
| Date Received | 2011-10-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2011-10-20 |