MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-12-05 for SMART MONITOR manufactured by Manufactured For Microport Crm S.r.l..
[177369690]
Reportedly, during first installation for association with an icd, the status led of the subject home monitor remains orange. It did not react to any health check.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2019-00668 |
| MDR Report Key | 9414896 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-12-05 |
| Date of Report | 2020-03-20 |
| Date of Event | 2019-11-13 |
| Date Facility Aware | 2019-11-13 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2019-12-05 |
| 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 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92140 |
| 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 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92140 |
| 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 | 2019-12-05 |
| Returned To Mfg | 2019-11-18 |
| Model Number | SMART MONITOR |
| Catalog Number | SMART MONITOR |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 92140 FR 92140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-12-05 |