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.
[181753017]
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
[181753018]
A user facility's biomedical technician reported an aquab plus 1500 device had a motor protection breaker trip on the stage 1 and the ro shut down. The biomedical technician replaced the motor protection breaker in aquab stage 1. This did not correct the problem. The biomedical technician determined the issue was the power distribution box and replaced middle fuse in stage 1 compartment to resolve the reported issue. The biomedical technician stated there was evidence of overheating found on one terminal lug of motor protection breaker. The biomedical technician stated that they noticed heat discoloration on one of the terminal lugs when replacing the part. A picture was provided which showed the damage from overheating on the terminal lug. The biomedical technician stated that the 600v rated cartridge fuse was replaced in the stage 1 compartment in the power distribution box, and the machine was returned to service. There was no patient involvement. It was reported that the part was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010850471-2020-00002 |
| MDR Report Key | 9779482 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-03 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-03-31 |
| 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 |
| 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 |