BASE SYS BI70002000 O-ARM SYS O2 Adverse Event — Malfunction (MDR 3004785967-2020-00503)
BASE SYS BI70002000 O-ARM SYS O2 Adverse Event — Malfunction (MDR 3004785967-2020-00503) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: BASE SYS BI70002000 O-ARM SYS O2; Generic name: INSTRUMENT, STEREOTAXIC; Manufacturer: MEDTRONIC NAVIGATION, INC (LITTLETON).
| Device | BASE SYS BI70002000 O-ARM SYS O2 |
|---|---|
| Generic name | INSTRUMENT, STEREOTAXIC |
| Manufacturer | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Report number | 3004785967-2020-00503 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | H3) THE DOOR SWITCH ASSEMBLY WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. TESTING FOUND THAT THE RELEASE MECHANISM WAS NOT OPERATING AS DESIGNED AS IT WOULD STICK. ADDITIONALLY, THE UNIT INTERMITTENTLY FAILED CONTINUITY TESTING. CONTINUATION OF D11) PN: BI71000166, LN: AV1254-1017/MPS103F. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803 |
| Source | openFDA MAUDE (device adverse events) |
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