MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-10-25 for OPTIMA XPN 100 CENTRIFUGE A94469 manufactured by Beckman Coulter.
[90955359]
The fse stated that the cause of the shock was determined to be damage to the white insulating film located in between the heatsink and u48 ic chip. The damage to the insulating film resulted in direct contact of the board circuit with the heatsink, which the fse came in contact with when he received the shock. The inverter board is an internal pc board located inside the centrifuge enclosure, and therefore this failure would not present a safety risk to the end user. The fse measured the voltage at the heatsink due to the loss of insulation and reported the reading to be 130 volts. The fse reported that the issue was resolved by replacing the damaged insulating film with the film from the inverter board that had just been removed from the instrument. This restored the insulation of the heatsink. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[90955360]
The field service engineer (fse) reported that receiving an electrical shock while performing a service activity on an internal instrument component (inverter board) of an optima xpn-100 centrifuge. There was no reported injury. The fse did not seek medical attention.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007448124-2017-00001 |
| MDR Report Key | 6978156 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-10-25 |
| Date of Report | 2017-09-26 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-09-26 |
| Device Manufacturer Date | 2017-06-01 |
| Date Added to Maude | 2017-10-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. LAURIE O'RIORDAN |
| Manufacturer Street | 11800 SW 147TH AVENUE |
| Manufacturer City | MIAMI FL 33196 |
| Manufacturer Country | US |
| Manufacturer Postal | 33196 |
| Manufacturer G1 | BECKMAN COULTER |
| Manufacturer Street | 5350 LAKEVIEW PARKWAY SOUTH DR |
| Manufacturer City | INDIANAPOLIS IN 46268 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46268 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIMA XPN 100 CENTRIFUGE |
| Generic Name | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
| Product Code | JQC |
| Date Received | 2017-10-25 |
| Model Number | NA |
| Catalog Number | A94469 |
| Lot Number | NA |
| Operator | SERVICE PERSONNEL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECKMAN COULTER |
| Manufacturer Address | 250 S KRAEMER BLVD BREA CA 92821 US 92821 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-25 |