MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-09-14 for GE PROTEUS AND/OR CARESTREAM X-RAY SYSTEMS manufactured by Ge Healthcare,.
[19909287]
Note: this event was originally filed on (b)(4) 2011, under form 3500. Varian medical systems received a ge (b)(4) reload with a varian a-195 insert for failure analysis. The customer (b)(6), returned this tube unit to varian with the x-ray tube service report stating that, "oil heated up enough to melt the plastic/acrylic port. This allowed all of the oil to drain out of the tube into the collimator. " under the heading reason for return, the box "oil leak" was checked and also the "other" stated, "shattered insert. " rep from varian, (b)(6), ge, and (b)(4) met on conference calls on (b)(6) 2011. From these discussions, it was discovered that the ge proteus system had an old version of software (ver. 5. 57) installed on it that was known to cause this type of failure. Ge's records show a software update to version 5. 59 in 2009 to prevent this type of known failure. (b)(6) is responsible for servicing their own machines, and could not account for the v 5. 57 software on the proteus system at the time of the failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1717855-2011-00002 |
| MDR Report Key | 2253457 |
| Report Source | 99 |
| Date Received | 2011-09-14 |
| Date of Report | 2011-08-05 |
| Date of Event | 2011-06-16 |
| Date Mfgr Received | 2011-06-16 |
| Device Manufacturer Date | 2007-07-01 |
| Date Added to Maude | 2012-06-28 |
| 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 | LINDA CHATWIN |
| Manufacturer Street | 1678 SOUTH PIONEER ROAD |
| Manufacturer City | SALT LAKE CITY UT 84104 |
| Manufacturer Country | US |
| Manufacturer Postal | 84104 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GE PROTEUS AND/OR CARESTREAM X-RAY SYSTEMS |
| Generic Name | X-RAY SYSTEMS |
| Product Code | KOP |
| Date Received | 2011-09-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE, |
| Manufacturer Address | 3000 N. GRANDVIEW BLVD. WAUKESHA WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-09-14 |