MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-13 for AFINION 1115176 manufactured by Abbott Diagnositcs Technologies As.
[188868792]
The customer had run an afinion test. And removed the cassette. As she touched and closed the lid of the analyzer she felt an electric shock and saw a sharp gleam/light, followed by a bang and a smell of burn. The user reported 30 minutes of pain in her hand and felt fine after that. There was a power outage and short circuit power failure in the office. The user did not need any kind of medical treatment after the incident. The user has experienced other instances of static electricity. The staff has discussed if they should get special rubber mats to prevent static electricity since some of them experience static electricity on a regular basis when touching different medical equipment, especially their centrifuge, but also in general in the office as door handles, between themselves etc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003045237-2020-00001 |
| MDR Report Key | 9832548 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-03-13 |
| 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 | MS MONICA VALLESTAD |
| Manufacturer Street | KJELS P.O.BOX 6863 RODEL |
| Manufacturer City | OSLO, 0504 |
| Manufacturer Country | NO |
| Manufacturer Postal | 0504 |
| Manufacturer G1 | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
| Manufacturer Street | KJELS P.O.BOX 6863 RODEL |
| Manufacturer City | OSLO, 0504 |
| Manufacturer Country | NO |
| Manufacturer Postal Code | 0504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFINION |
| Generic Name | ANALYZER |
| Product Code | JQT |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-02-25 |
| Model Number | 1115176 |
| Catalog Number | 1115176 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSITCS TECHNOLOGIES AS |
| Manufacturer Address | KJELS?SVEIEN 161 P.O.BOX 6863 RODEL?KKA OSLO, 0504 NO 0504 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-13 |