MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2007-12-21 for MAMORAY COMPACT EOS MAMORAYCOMPACTEOS ED9PS manufactured by Agfa Healthcare Gmbh.
[17399543]
A mamoray compact e. O. S. Caught fire and was badly damaged, forcing evacuation of the clinic. No one was injured.
Patient Sequence No: 1, Text Type: D, B5
[17680273]
The investigation is not complete. Root cause for the fire has not been determined at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1063474-2007-00002 |
| MDR Report Key | 969479 |
| Report Source | 01,05,06 |
| Date Received | 2007-12-21 |
| Date of Report | 2007-12-21 |
| Date of Event | 2007-12-07 |
| Date Mfgr Received | 2007-12-07 |
| Device Manufacturer Date | 2002-09-01 |
| Date Added to Maude | 2008-04-09 |
| 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 | DR. RAY MYERS |
| Manufacturer Street | 10 S. ACADEMY ST. |
| Manufacturer City | GREENVILLE SC 29601 |
| Manufacturer Country | US |
| Manufacturer Postal | 29601 |
| Manufacturer Phone | 8644211827 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAMORAY COMPACT EOS |
| Generic Name | AUTOMATIC RADIOGRAPHIC FILM PROCESSOR |
| Product Code | EGY |
| Date Received | 2007-12-21 |
| Model Number | MAMORAYCOMPACTEOS |
| Catalog Number | ED9PS |
| Lot Number | NA |
| ID Number | TYPE 5120/200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 973134 |
| Manufacturer | AGFA HEALTHCARE GMBH |
| Manufacturer Address | MAX PLANCK STRASSE 1 PEISSENBERG GM D82380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-21 |