MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-29 for SYNGO DYNAMICS 10091805 manufactured by Siemens Healthcare Gmbh.
[145399288]
Resubmission of initial report due to report code error. The investigation is on-going. It has not yet been determined whether the syngo dynamics product has caused or contributed to the loss of data. No injury is associated with this issue. No data mix-up or loss occurred which would result in the need for a patient rescan. A supplemental report will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[145399289]
A potential loss of clinically-relevant data which may be unrecoverable was reported. The investigation into the root cause and recoverability of the data is ongoing. The clinical relevance of the potentially lost data is that the user no longer has the historical study images available if a comparison with newer images is desired, however the clinical studies and reports created from the read of the image studies are still available in the sites his. There are no injuries attributed to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808157-2018-26002 |
| MDR Report Key | 8560709 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-29 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-04-13 |
| Date Mfgr Received | 2018-06-18 |
| Date Added to Maude | 2019-04-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANASTASIA SOKOLOVA |
| Manufacturer Street | 40 LIBERTY BLVD, MC 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486478 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH |
| Manufacturer Street | HENKESTRASSE 127 |
| Manufacturer City | ERLANGEN, 91052 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNGO DYNAMICS |
| Generic Name | PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM |
| Product Code | LLZ |
| Date Received | 2019-04-29 |
| Model Number | 10091805 |
| 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 HEALTHCARE GMBH |
| Manufacturer Address | HENKESTRASSE 127 ERLANGEN, 91052 GM 91052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-29 |