SMARTVIEW Adverse Event — Malfunction (MDR 1000165971-2020-00374)
SMARTVIEW Adverse Event — Malfunction (MDR 1000165971-2020-00374) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SMARTVIEW; Generic name: PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS; Manufacturer: SORIN GROUP ITALIA S.R.L. - CRM FACILITY.
| Device | SMARTVIEW |
|---|---|
| Generic name | PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS |
| Manufacturer | SORIN GROUP ITALIA S.R.L. - CRM FACILITY |
| Report number | 1000165971-2020-00374 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Narrative | REPORTEDLY, THE SUBJECT HOME MONITOR WAS SET-UP IN JULY 2019 AND CONNECTED ONLY UNTIL 29 OF AUGUST 2019 AS IF IT WAS UNPLUGGED FROM THE WIREX. THE STATUS LIGHT OF THE SUBJECT HOME MONITOR REMAINS ORANGE, BOOTING IN LOOP. |
| Source | openFDA MAUDE (device adverse events) |
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