MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-04 for SMARTVIEW SMARTVIEW GPRS manufactured by Sorin Group Italia S.r.l. - Crm Facility.
[132225353]
During the pairing of the subject home monitor on (b)(6) 2018, the patient reported by phone that the received smartview was scratched, and badly packaged. Pictures were sent, which showed that the two bags containing the adaptors were missing and the cable was not properly bended nor tightened in its package. Reportedly, during the pairing several problems occurred: it was difficult to keep the green light after plugging to the mains, the remote monitoring needed at least 2 minutes to start, and green light switched off. In a second attempt, the remote monitoring started and could be associated with the defibrillator. During a remote follow up after the first transmission, the back office noticed that the transmission was not done and an email on 11 dec 2018 from the patient was received, reporting that it switched off after 15 minutes from the starting and later on it switched on again. A manual transmission was performed by the patient but it did not work. Reset has been done and tried again, without success.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000165971-2019-00012 |
| MDR Report Key | 8216441 |
| Date Received | 2019-01-04 |
| Date of Report | 2019-04-24 |
| Date of Event | 2018-12-11 |
| Date Facility Aware | 2018-12-11 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-01-04 |
| 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 REAUMUR |
| Manufacturer City | CLAMART, 92140 |
| Manufacturer Country | FR |
| Manufacturer Postal | 92140 |
| Manufacturer Phone | 0146013665 |
| Manufacturer G1 | EOLANE BLD J. BAPTISTE COLBERT 49520 COMBREE FR |
| Manufacturer Street | PARC D'AFFAIRES NOVEOS 4 AVENUE REAUMUR |
| 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 |
| Generic Name | UNKNOWN |
| Product Code | OSR |
| Date Received | 2019-01-04 |
| Returned To Mfg | 2019-01-02 |
| Model Number | SMARTVIEW GPRS |
| Catalog Number | SMARTVIEW GPRS |
| 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 REAUMUR CLAMART, 92140 FR 92140 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-04 |