MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2015-06-18 for SYMBIA S 8717741 manufactured by Siemens Medical Solutions Usa, Inc., Mi Group.
[16561949]
Manufacturer narrative: siemens molecular imaging became aware on (b)(6) 2015 through a discussion with the risk manager at (b)(6) hospital, in (b)(6), that a pt injury occurred on (b)(6) 2015. The pt rolled off and fell from the patient handling system (system bed) resulting in a broken arm. The site risk manager stated that there was no malfunctions of the device as the pt was left unattended while sleeping and rolled off at the conclusion of the scan. The pt was awoken by the beep sound made at the end of the study. There were no product defects or labeling deficiencies found. The operator of the system was not harmed in this event. Customer narrative: "camera beeped at the end of a cardiac spect scan, this woke the pt. The pt rolled off the phs falling to the floor. Pt had ct scan and x-ray".
Patient Sequence No: 1, Text Type: D, B5
[39577015]
During follow-ups on this complaint, we became aware on 06/22/2015 that the reported date of event ((b)(6) 2015) was incorrect. The correct date of event ((b)(6) 2015) is being submitted via this supplement report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423253-2015-00005 |
| MDR Report Key | 4860087 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2015-06-18 |
| Date of Report | 2015-06-10 |
| Date of Event | 2015-05-30 |
| Date Mfgr Received | 2015-06-12 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2015-06-23 |
| 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 | 3 |
| Event Location | 3 |
| 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 | SYMBIA S |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2015-06-18 |
| Model Number | 8717741 |
| 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 | 1. Required No Informationntervention | 2015-06-18 |