MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-18 for SMARTVIEW HOTSPOT SMARTVIEW HOTSPOT PSTN manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[145507505]
Reportedly, on (b)(6) 2019 the patient powered the 3g adapter to the landline, as well as the subject home monitor. When the home monitor was turned on, the patient initiate transfer (pit) button immediately displayed a constant red light, and the installation of the unit could not be completed. On (b)(6) 2019, the subject home monitor was tested at the (b)(4) distributor, and the reported issue could be reproduced.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2019-00218 |
| MDR Report Key | 8526429 |
| Date Received | 2019-04-18 |
| Date of Report | 2019-10-02 |
| Date of Event | 2019-03-13 |
| Date Facility Aware | 2019-03-22 |
| Date Mfgr Received | 2019-09-17 |
| Date Added to Maude | 2019-04-18 |
| 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 | ELODIE VINCENT |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R 4 AVENUE R |
| Manufacturer City | CLAMART 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92140 |
| Manufacturer Phone | 0146013665 |
| Manufacturer G1 | EOLANE BLD J. BAPTISTE COLBERT 49520 COMBREE FRANCE |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE R 4 AVENUE R |
| Manufacturer City | CLAMART 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SMARTVIEW HOTSPOT |
| Generic Name | PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS |
| Product Code | OSR |
| Date Received | 2019-04-18 |
| Returned To Mfg | 2019-06-07 |
| Model Number | SMARTVIEW HOTSPOT PSTN |
| Catalog Number | SMARTVIEW HOTSPOT PSTN |
| 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 | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
| Manufacturer Address | PARC D'AFFAIRES NOVEOS 4 AVENUE R?AUMUR 4 AVENUE R?AUMUR CLAMART 92140 FR 92140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-18 |