MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-31 for SMART MONITOR manufactured by Manufactured For Microport Crm S.r.l..
[181786835]
The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
Patient Sequence No: 1, Text Type: N, H10
[181786836]
Reportedly, the patient initiated transfer (pit) button of the subject home monitor remains lit in red at the end of two installation attempts. The device did not connect to the network at the patient's address, while the network seems to be good enough for the connection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2020-00243 |
| MDR Report Key | 9654103 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-31 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-01-06 |
| Date Facility Aware | 2020-01-06 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-01-31 |
| 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 | LAURA OUAKI |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R |
| Manufacturer City | CLAMART, 92140 |
| Manufacturer Country | FR |
| Manufacturer Phone | 146013429 |
| Manufacturer G1 | EOLANE BLD J. BAPTISTE COLBERT 49520 COMBREE FRANCE |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R |
| Manufacturer City | CLAMART, 92140 |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMART MONITOR |
| Generic Name | PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS |
| Product Code | OSR |
| Date Received | 2020-01-31 |
| Returned To Mfg | 2020-01-20 |
| Model Number | SMART MONITOR |
| Catalog Number | SMART MONITOR |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MANUFACTURED FOR MICROPORT CRM S.R.L. |
| Manufacturer Address | PARC D'AFFAIRES NOVEOS 4 AVENUE R?AUMUR CLAMART, 92140 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |