MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-11-01 for E.CAM 5989079 manufactured by Siemens Medical Solutions Usa, Inc., Mi Group.
[3989178]
During use of an e. Cam gamma camera, the customer indicated hearing (relay) clicking-type noise from the tower behind the camera system gantry. The customer removed the patient from the system. There was no injury. The investigation of the event determined that the radial drive brake failed to engage. The detector continued to move slowly downward with no means of stopping the detector. A very specific set of circumstances must occur for this type of mechanical failure to recur: the brake had to fail, the axis with the faulty brake must be enabled above a patient, then there must be an event that takes down the power (touch pad, e-stop, actual power failure). This is the clicking-type noise that the customer heard. All of these faults and scenarios must occur within a 50-100ms time window after applying power to disengage the brake. There have not been any reported injuries associated to this failure during the entire product life-cycle dating back to 1997.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-2013-00005 |
| MDR Report Key | 3633703 |
| Report Source | 05,07 |
| Date Received | 2013-11-01 |
| Date of Report | 2013-10-21 |
| Date of Event | 2013-10-21 |
| Date Mfgr Received | 2013-10-21 |
| Date Added to Maude | 2014-03-12 |
| 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 | LAURA MEYER |
| Manufacturer Street | 2501 NORTH BARRINGTON RD. |
| Manufacturer City | HOFFMAN ESTATES IL 60192 |
| Manufacturer Country | US |
| Manufacturer Postal | 60192 |
| Manufacturer Phone | 8473046022 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E.CAM |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2013-11-01 |
| Model Number | 5989079 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS MEDICAL SOLUTIONS USA, INC., MI GROUP |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-01 |