MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-21 for DISSOLUTION UNIT-TESTED G047-80101 manufactured by Concord Manufacturing.
[139418164]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.?
Patient Sequence No: 1, Text Type: N, H10
[139418165]
A biomedical technician at a user facility reported a fresenius dissolution unit would not power on. The biomed confirmed that while servicing the machine, they touched the control board and received a slight electrical shock. The biomed confirmed they were not injured or harmed, and confirmed they did not need any medical intervention as a result of the issue. The biomed confirmed there were no visible sparks or arcing, and advised the control board functioned correctly and did not need to be replaced. The biomed confirmed there was no electrical issue with the machine, and confirmed they replaced the display board to resolve the original no power issue and return the machine to service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2019-00850 |
| MDR Report Key | 8439177 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-02-28 |
| Date Mfgr Received | 2019-03-22 |
| Device Manufacturer Date | 2012-08-27 |
| Date Added to Maude | 2019-03-21 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| Manufacturer G1 | CONCORD MANUFACTURING |
| Manufacturer Street | DIRECTOR, QUALITY SYSTEMS 4040 NELSON AVENUE |
| Manufacturer City | CONCORD CA 94520 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94520 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISSOLUTION UNIT-TESTED |
| Generic Name | BLENDER/MIXER |
| Product Code | JRO |
| Date Received | 2019-03-21 |
| Catalog Number | G047-80101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONCORD MANUFACTURING |
| Manufacturer Address | 4040 NELSON AVENUE CONCORD CA 94520 US 94520 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-21 |