MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-01-26 for MAICAM 180 PORTABLE CARDIAC CAMERA CAM001 manufactured by Segami & Mai.
[21249891]
Continued failures of gamma detection components on new gamma camera in 2008 resulted in the rescheduling of 16 patients for follow-up stress portion of nuclear cardiology exams. Manufacturer arranged for temporary use of loaner system on 1/26/2008, while repairs were made to original system. Manufacturer's loaner camera failed with similar problems the same day, at physician's office causing delay and additional patient rescheduling. The new gamma camera also is experiencing considerable issues and failures related to a beta-software release, resulting in time-consuming manual data processing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005196 |
| MDR Report Key | 991012 |
| Date Received | 2008-01-26 |
| Date of Report | 2008-01-26 |
| Date of Event | 2008-01-26 |
| Date Added to Maude | 2008-02-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAICAM 180 PORTABLE CARDIAC CAMERA |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2008-01-26 |
| Model Number | MAICAM 180 |
| Catalog Number | CAM001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 960673 |
| Manufacturer | SEGAMI & MAI |
| Manufacturer Address | 8325 GUILFORD RD, STE B 9051 RED BRANCH RD, STE C COLUMBIA MD 21056 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-01-26 |