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 2019-09-04 for GRANUFLO DISSOLUTION TANK RTLG047-80101 manufactured by Concord Manufacturing.
[156413363]
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
[156413364]
A user facility biomedical technician (biomed) reported that a fresenius dry acid mixer motor run for a few seconds then tripped the gfi power switcher. The mixer motor got wet and smoked when it was hosed down. There was no patient involvement. Additional information was requested, however to date not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2937457-2019-02818 |
| MDR Report Key | 8959816 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-09-04 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-08-20 |
| Date Mfgr Received | 2019-08-20 |
| Device Manufacturer Date | 2006-08-02 |
| Date Added to Maude | 2019-09-04 |
| 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 | GRANUFLO DISSOLUTION TANK |
| Generic Name | BLENDER/MIXER |
| Product Code | JRO |
| Date Received | 2019-09-04 |
| Catalog Number | RTLG047-80101 |
| 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 | 2019-09-04 |