MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-07-15 for SYMBIA S 08717741 manufactured by Siemens Medical Solutions Usa, Inc..
[6030321]
Manufacturer narrative: on 06/22/2015 siemens became aware of a complaint event that indicated a patient sustained a shallow cut to their left hand during the movement of the symbia system bed by the operator. On 06/30/2015 in response to a request for additional information to investigation this complaint, siemens was informed that the patient cut resulted in stitches to the area near the base of the thumb. No product defects or failures were found. A review of product labeling determined that instructions were adequate with regard to the operation and safety instructions of the symbia s system. The patient injury was the result of user error. The operator was using the hand controller to manually move the patient bed and did not ensure that the patient kept all body parts out of the way of the moving table. No operator injury occurred. Customer narrative: "after the exam, the technologist used the hand controller to move the table away from the gantry horizontally. During this movement the patient. During on pallet supine feet facing the gantry, moved their left hand and placed it behind their back, sustaining a shallow cut to their left hand. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423253-2015-00006 |
| MDR Report Key | 4925821 |
| Report Source | 05,07 |
| Date Received | 2015-07-15 |
| Date of Report | 2015-06-22 |
| Date of Event | 2015-06-19 |
| Date Mfgr Received | 2015-06-23 |
| Device Manufacturer Date | 2007-01-01 |
| Date Added to Maude | 2015-07-21 |
| 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 | SYMBIA S |
| Generic Name | GAMMA CAMERA |
| Product Code | IYX |
| Date Received | 2015-07-15 |
| Model Number | 08717741 |
| 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. |
| Manufacturer Address | 2501 NORTH BARRINGTON RD. HOFFMAN ESTATES IL 60192 US 60192 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-15 |