MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-06-26 for E-CAM E CAM * manufactured by Siemens Medical Solutions Usa, Inc..
[878795]
A series of studies were done on a particular patient. Staff were unable to locate one of the studies afterwards and it was discovered in a different patient's file. The second patient was scanned nearly a year prior. Since staff were initially unable to locate the study, a repeat procedure was necessary. The vendor states that the technician must have selected the wrong patient, but the number of steps necessary to accomplish this, along with other details, suggest this was more likely a software error. This is particularly true since it was not a currently scheduled patient. Selecting a patient from many months prior is unlikely. The technician is convinced this was a software error and not a staff error for a number of reasons. ====================== manufacturer response for gamma camera system======================vendor says this was user error but our staff do not agree with that finding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1069905 |
| MDR Report Key | 1069905 |
| Date Received | 2008-06-26 |
| Date of Report | 2008-06-26 |
| Date of Event | 2008-05-15 |
| Report Date | 2008-06-26 |
| Date Reported to FDA | 2008-06-26 |
| Date Added to Maude | 2008-07-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-CAM |
| Generic Name | GAMMA CAMERA SYSTEM |
| Product Code | IYX |
| Date Received | 2008-06-26 |
| Model Number | E CAM |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 6 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1036813 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC. |
| Manufacturer Address | 51 VALLEY STREAM PARKWAY MALVERN PA 19355 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-06-26 |