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 2014-05-20 for SYMBIA S 8717741 manufactured by Siemens Medical Solutions Usa, Inc. Mi Group.
[4393320]
A patient was presented for a nuclear medicine study. The patient was positioned on the patient handling system (the patient bed associated with the system). The patient was left unattended and fell off the patient handling system and reportedly sustained an injury to the head. During siemens' follow-up with the site for additional information on (b)(6) 2014, it was reported that the patient was removed from life support and had expired. Siemens was not able to obtain information regarding the reason the patient was removed from life support or any potential relationship to the fall from the patient handling system or the patient's preexisting condition; cancer. Local service engineer investigated the system associated with the incident and confirmed the patient handling system was functioning properly and no device defects or malfunctions were found. The system was not in motion at the time of the incident. A review of the product user manual indicated that the product labeling adequately instructs users to monitor the patients at all times while on the system and that it is the user's responsibility to monitor the system to avoid any risk of injury.
Patient Sequence No: 1, Text Type: D, B5
[39245738]
This supplement provides the "date received by manufacturer" information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423253-2014-00003 |
| MDR Report Key | 3834418 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-05-20 |
| Date of Report | 2014-05-09 |
| Date of Event | 2014-05-08 |
| Date Mfgr Received | 2014-05-12 |
| Device Manufacturer Date | 2006-11-01 |
| Date Added to Maude | 2014-05-29 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURA MEYER |
| Manufacturer Street | 2501 N. 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 | 2014-05-20 |
| 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. Death; 2. Hospitalization; 3. Required No Informationntervention | 2014-05-20 |