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 2019-03-19 for AQUABPLUS 1500 G02040105-US manufactured by Vivonic Gmbh.
[139164461]
The manufacturer investigation is in process. A supplemental mdr will be submitted upon completion of this activity.?
Patient Sequence No: 1, Text Type: N, H10
[139164462]
A user facility's biomedical technician reported an aquab plus 1500 had a power switch that was found to have a burnt connector on leg one. Upon follow up, it was reported that the power switch was replaced to resolve the reported issue. The machine has been returned to service and it's confirmed that there was no patient involvement associated with the reported event. The sample is available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010850471-2019-00001 |
| MDR Report Key | 8431568 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-03-19 |
| Date of Report | 2019-05-07 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-05-07 |
| Date Added to Maude | 2019-03-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MATTHEW AMARAL |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999758 |
| Manufacturer G1 | VIVONIC GMBH |
| Manufacturer Street | KURUFUERST-EPPSTEIN-RING 4 |
| Manufacturer City | SAILAUF 63877 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 63877 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUABPLUS 1500 |
| Generic Name | SUBSYSTEM, WATER PURIFICATION |
| Product Code | FIP |
| Date Received | 2019-03-19 |
| Catalog Number | G02040105-US |
| Device Availability | Y |
| Device Age | MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VIVONIC GMBH |
| Manufacturer Address | KURUFUERST-EPPSTEIN-RING 4 SAILAUF 63877 GM 63877 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-19 |