MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-02-12 for INTRABEAM PRS 500 000001-4356-811 manufactured by Carl Zeiss Meditec Ag.
[3300773]
A healthcare professional encountered several coded error messages when preparing an intrabeam miniature therapeutic x-ray device for intraoperative radiotherapy (iort). The healthcare professional could not resolve the problem in a telephone conversation with the mfr's technical support rep. The surgeon made the decision to proceed with the surgical portion of the procedure without iort for one pt and to reschedule a second pt.
Patient Sequence No: 1, Text Type: D, B5
[10527871]
A field service engineer visited the site and determined that the intrabeam system failed to locate the file that contains the sqa equipment inventory. The file was located by the field service engineer and moved back to the correct folder. It was reported that the healthcare professional moved the file in error while performing file maintenance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615010-2013-00002 |
| MDR Report Key | 3001890 |
| Report Source | 05,06 |
| Date Received | 2013-02-12 |
| Date of Report | 2013-02-12 |
| Date of Event | 2013-01-14 |
| Date Mfgr Received | 2013-01-14 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2013-04-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JUDY BRIMACOMBE |
| Manufacturer Street | 5160 HACIENDA DR |
| Manufacturer City | DUBLIN CA 945687562 |
| Manufacturer Country | US |
| Manufacturer Postal | 945687562 |
| Manufacturer Phone | 9255574616 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG |
| Manufacturer Street | CARL ZEISS STRASSE 22 |
| Manufacturer City | OBERKOCHEN 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTRABEAM |
| Generic Name | SYSTEM, THERAPEUTIC, X-RAY |
| Product Code | JAD |
| Date Received | 2013-02-12 |
| Model Number | PRS 500 |
| Catalog Number | 000001-4356-811 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG |
| Manufacturer Address | CARL ZEISS STRASSE 22 OBERKOCHEN 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-12 |