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 2020-03-03 for AQUABPLUS 1500 G02040105-US manufactured by Vivonic Gmbh.
[181766994]
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
[181766995]
A user facility's biomedical technician reported that an aquab plus 1500 had an overheated pin on the 24 volt power supply power cable. The plastic on the pin connection was found to be blackened. The biomed stated they found the damage during machine repair. There was no smoke, burning smell, flame, spark, or arcing noted. There was no other damage to any other components related to the reported events. The biomed provided a picture which showed the blackened pin connection. The damaged wire connection and the 24 volt power supply was replaced and the machine operated properly. The biomed reported that the sample has been returned to the manufacturer. There was no patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010850471-2020-00001 |
| MDR Report Key | 9779458 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-09 |
| Date Mfgr Received | 2020-03-24 |
| Date Added to Maude | 2020-03-03 |
| 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 |
| 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 | 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 | 2020-03-03 |
| Returned To Mfg | 2020-02-27 |
| Model Number | AQUABPLUS 1500 |
| Catalog Number | G02040105-US |
| Device Availability | R |
| Device Age | MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-03 |