MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-17 for MOBILETT MIRA MAX 10594739 manufactured by Siemens Healthcare Gmbh.
[142510259]
Resubmission of initial report as per fda on 4/3/19. The investigation showed the issue occurred due to rough handling of main power cable and connectors. Instructions on how to use/handle the cable and perform a regular check are available in "instructions for use" (ifu). It is recommended to follow these instructions to prevent such occurrences.
Patient Sequence No: 1, Text Type: N, H10
[142510260]
It was reported to siemens that a loud popping sound occurred on the mobilett mira max. The unit was plugged in to the main power source. The system was not operational after the incident. There is no patient involvement in this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808157-2018-52728 |
| MDR Report Key | 8524603 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-17 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-10-12 |
| Date Mfgr Received | 2018-10-12 |
| Date Added to Maude | 2019-04-17 |
| 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 | 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 | MOBILETT MIRA MAX |
| Generic Name | MOBILE X-RAY SYSTEM |
| Product Code | IZL |
| Date Received | 2019-04-17 |
| Model Number | 10594739 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2019-04-17 |