MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-05-08 for DISSOLUTION UNIT-TESTED DRY ACID MIXER- GRAN G047-80101 manufactured by Concord Manufacturing.
[144416235]
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
[144416236]
A biomedical technician (biomed) at a user facility reported that a fresenius dry acid mixer was seen smoking and giving off a burning smell during use. Upon inspection, the biomed found interior wiring that was visibly burned and melted. A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction. The wiring was the original fresenius part on the machine. The biomed reported that there was no damage observed on any other components, or any other additional issues, associated with the burned and melted wiring. The biomed confirmed that the dry acid mixer was being replaced rather than being repaired. The dry acid mixer was scheduled to be returned to the manufacturer for physical evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2019-01373 |
| MDR Report Key | 8590912 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-08 |
| Date of Report | 2019-06-04 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-06-04 |
| Device Manufacturer Date | 2003-04-22 |
| Date Added to Maude | 2019-05-08 |
| 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 | 2019-05-08 |
| Model Number | DRY ACID MIXER- GRAN |
| Catalog Number | G047-80101 |
| Lot Number | N/A |
| 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 | 2019-05-08 |