MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-11-16 for CLEARSIGN? AMPLIFIER FOR LABSYSTEM? PRO EP RECORDING SYSTEM M0042002022R0 2002022 manufactured by Boston Scientific - Fremont (ce).
[60040471]
(b)(4). Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[60040472]
It was reported that the amplifier was exposed to high current. During preventative maintenance of a clearsign" amplifier for labsystem" pro ep recording system it was noted that the amplifier was exposed to too high current. The power supplied in the ep lab to the clearsign" amplifier was between was 240v-250v. Multiple errors in the system log were noted. The isolation transformer in the lab was modified to produce correct output (230 v). The clearsign" amplifier was exchanged. No patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134265-2016-10155 |
| MDR Report Key | 6106841 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-16 |
| Date of Report | 2016-10-18 |
| Date of Event | 2016-10-18 |
| Date Mfgr Received | 2016-10-17 |
| Date Added to Maude | 2016-11-16 |
| 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 | EMP. LINDA LEIMER |
| Manufacturer Street | ONE SCIMED PLACE |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal | 55311 |
| Manufacturer Phone | 7634941700 |
| Manufacturer G1 | BOSTON SCIENTIFIC - FREMONT (CE) |
| Manufacturer Street | 47215 LAKEVIEW BLVD NORTH DOCK |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94538 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEARSIGN? AMPLIFIER FOR LABSYSTEM? PRO EP RECORDING SYSTEM |
| Generic Name | AMPLIFIER AND SIGNAL CONDITIONER, TRANSDUCER SIGNAL |
| Product Code | DRQ |
| Date Received | 2016-11-16 |
| Model Number | M0042002022R0 |
| Catalog Number | 2002022 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC - FREMONT (CE) |
| Manufacturer Address | 47215 LAKEVIEW BLVD NORTH DOCK FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-16 |