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 2000 G02040107-US manufactured by Vivonic Gmbh.
[181796354]
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
[181796355]
A user facility's biomedical technician reported an aquab plus 2000 device had a p1s failure, the 24v power supply burned out and 2 fuses in the power disconnect box were burnt out. The area technical operations manager (atom) stated that the fuses were burned and a burning smell was observed. There was no smoke, flame, spark, arcing, or other visible damage related to the burned fuses in the power disconnect board. A picture of the power disconnect board was provided, which showed the burned fuses. The atom stated that the issue was discovered when they were moving into the facility, and there was no patient involvement. The fuses, the motor circuit breaker, the 24v power supply, and the motor contactor were replaced to resolve the issue. The type of fuse replaced was unknown. The device was returned to service. The parts were returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010850471-2020-00003 |
| MDR Report Key | 9780858 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-03 |
| Date of Report | 2020-04-02 |
| Date of Event | 2019-12-02 |
| Date Mfgr Received | 2020-03-25 |
| 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 2000 |
| Generic Name | SUBSYSTEM, WATER PURIFICATION |
| Product Code | FIP |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-03-02 |
| Catalog Number | G02040107-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 |