MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-01-17 for MAGNETOM AVANTO FIT 10849579 manufactured by Siemens Healthcare Gmbh- Mr.
[177537644]
Siemens is conducting a thorough investigation of the reported events. As this event is under investigation, a root cause has not yet been determined. A supplement report will be filed upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[177537645]
It was reported to siemens that an adverse event occurred while operating the magnetom avanto fit system. The user reported that a patient fractured three ribs during a breast examination when raising the arms. No further details were provided regarding the procedure. The patient was taken to the emergency room for evaluation and the fractured ribs were confirmed. It is not known what medical treatment was provided. Siemens has requested additional information in order to conduct an investigation of the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808157-2020-14977 |
| MDR Report Key | 9601185 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-01-17 |
| 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 | MEREDITH ADAMS |
| Manufacturer Street | 40 LIBERTY BLVD. 65-1A |
| Manufacturer City | MALVERN PA 19355 |
| Manufacturer Country | US |
| Manufacturer Postal | 19355 |
| Manufacturer Phone | 6104486461 |
| Manufacturer G1 | SIEMENS HEALTHCARE GMBH- MR |
| Manufacturer Street | HENKESTRASSE 127 |
| Manufacturer City | ERLANGEN, GERMANY 91052 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 91052 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNETOM AVANTO FIT |
| Generic Name | SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING |
| Product Code | LNH |
| Date Received | 2020-01-17 |
| Model Number | 10849579 |
| 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- MR |
| Manufacturer Address | HENKESTRASSE 127 ERLANGEN, GERMANY 91052 GM 91052 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-17 |